<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03832959</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-ABL-2018-55</org_study_id>
    <nct_id>NCT03832959</nct_id>
  </id_info>
  <brief_title>Esophageal Damage Protection During Pulmonary Vein Ablation. Pilot Study.</brief_title>
  <official_title>Evaluation of Esophageal Damage During Conventional Pulmonary Vein Ablation Procedures and Potential Strategies to Protect the Esophagus. Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Catheter ablation of atrial fibrillation with electrical isolation of the pulmonary veins in&#xD;
      the left atrium carries risk of esophagus thermal lesion. EnsoETM is a device . This study&#xD;
      evaluates the benefit of using the EnsoETM, a device device for esophageal temperature&#xD;
      adjustments, during catheter ablation of atrial fibrillation. Half of participants will&#xD;
      undergo esophageal temperature adjustment during pulmonary vein catheter ablation, while the&#xD;
      other half will undergo catheter ablation with no esophageal temperature adjustment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. THEORETICAL FRAMEWORK. APPROACH TO THE PROBLEM&#xD;
&#xD;
      Background and justification&#xD;
&#xD;
      Atrial fibrillation is the most common type of heart arrhythmia. Electrical isolation of the&#xD;
      pulmonary veins in the left atrium with ablation is standard therapy in the invasive&#xD;
      treatment of atrial fibrillation. One of the risks of this intervention is thermal lesion of&#xD;
      the esophagus, since it is in contact with the posterior wall of the left atrium. The energy&#xD;
      applied for electrical isolation via either radiofrequency or cryotherapy can cause thermal&#xD;
      lesions due to proximity with the esophagus and the vagus nerve/parasympathetic nervous&#xD;
      system of the upper digestive tract. The incidence is not well established and data in the&#xD;
      existing scarce publications show a very wide range, from 3 to 60%, according to the&#xD;
      definition and means of the study used. The most recent systematic studies show values around&#xD;
      40-50%. The lesions observed vary in degree, from erythema or minor erosion to ulcers of the&#xD;
      esophageal mucosa, including local hematomas, spasms, and esophageal/gastric motility&#xD;
      disorders and even atrial-esophageal fistula, the extreme consequence of thermal esophageal&#xD;
      lesion; the incidence of the latter is low (0.25%), but it has an elevated mortality. The&#xD;
      best examination to diagnose and evaluate these lesions in all phases is upper digestive&#xD;
      endoscopy or fibro esophagogastroscopy. Although it is routine in digestive services&#xD;
      throughout the world, enabling the direct visualization and characterization of lesions, this&#xD;
      technique is not performed systematically after ablation procedures, which explains the&#xD;
      contradictory data in the literature.&#xD;
&#xD;
      Likewise, the possible long-term consequences of minor lesions are unknown, which, in a large&#xD;
      number of patients are totally asymptomatic. For this reason, it cannot be ignored that acute&#xD;
      tissue damage, however minimal, could lead to future changes in the form of late onset&#xD;
      chronic esophageal pathology. The incidence and magnitude of esophageal involvement has been&#xD;
      directly related to the ablation technique and protocol. Most available studies have been&#xD;
      carried out in centers with ablation protocols that are significantly more aggressive than&#xD;
      those used in our care facility. For this reason, the investigators do not have reliable data&#xD;
      regarding the size of the problem in our center, which could present some differential&#xD;
      characteristics.&#xD;
&#xD;
      To date, the prevention of these esophageal lesions has entailed: limits in the energy&#xD;
      applied on the posterior wall of the left atrium (less power or shorter application time);&#xD;
      monitoring of the luminal esophageal temperature during radio frequency or cryotherapy&#xD;
      applications; stopping application early if certain temperatures considered risky were&#xD;
      reached. However, the success of luminal esophageal temperature monitoring in preventing&#xD;
      lesions varies widely, given that the temperature probes are very thin with respect to the&#xD;
      total diameter of the esophagus, their position varies with respect to the cardiac tissue&#xD;
      treated, and contact with the esophageal mucosa is inconstant. In fact, it has been reported&#xD;
      that the temperature probes used for monitoring can contribute to increasing thermal lesions,&#xD;
      given that their metal elements can boost direct heating/cooling of the tissue and make the&#xD;
      lesion larger and last longer. In fact, the incidence of esophageal lesions is very similar,&#xD;
      independent of the use of the temperature probe, or if it is a single or multi-sensor.&#xD;
      Another controversial aspect of these temperature probes is that their use can lead to - at&#xD;
      least potentially and in pursuit of safety - shorter, limited applications, which could cause&#xD;
      incomplete non-transmural lesions and hamper the correct treatment of patients, thereby&#xD;
      becoming a factor that increases the recurrence of atrial fibrillation. In addition, these&#xD;
      probes should be deployed during the procedure so they are as close as possible to the&#xD;
      application site (right or left veins depending on the time), which increases the procedure&#xD;
      and fluoroscopy time, with consequent risks for both the patient and the medical team. All&#xD;
      these limitations, together with significant economic cost overruns have meant that the use&#xD;
      of this approach in our care facilities has been minimal and only for research purposes.&#xD;
&#xD;
      Even if the possible long-term consequences of esophageal lesions are minimal, studying new&#xD;
      strategies for esophageal protection that are easy to implement and do not affect the&#xD;
      efficacy of ablation procedures is of great clinical and scientific interest. In this&#xD;
      context, there is a plan to use the probes to regulate and maintain patient temperature in&#xD;
      prolonged surgeries or critical units as a method of esophageal protection during ablation.&#xD;
      Multiple clinical studies have demonstrated the efficacy and safety of these probes in&#xD;
      different medical/surgical areas. In particular, they are indicated to minimize the&#xD;
      neurological damage associated with heart attacks through the induction of therapeutic&#xD;
      hypothermia. They are also indicated to reduce the temperature of patients with malignant&#xD;
      hyperthermia, to prevent unexpected peri-operative hypothermia, and to reduce elevated&#xD;
      intracranial pressure.&#xD;
&#xD;
      The prevention of esophageal lesions via temperature control (local cooling of the esophagus&#xD;
      when radiofrequency is used or heating when cryotherapy is used, thanks to various probe&#xD;
      configurations) has been investigated with mathematical models, preclinical models, and in&#xD;
      the clinical field in a preliminary way. Data are available that demonstrate its efficacy in&#xD;
      this approach, although with limitations in the number of cases and the systems used. In most&#xD;
      of these studies, prototypes of anterior probes were used, which are difficult to place and&#xD;
      require changes in the work routine, which has made the expansion of devices using this&#xD;
      approach more difficult up to now.&#xD;
&#xD;
      The appearance of a new, easier-to-use device for esophageal temperature adjustments&#xD;
      (EnsoETM, Attune Medical, Chicago, Illinois, USA) when managing patient temperature for a&#xD;
      large variety of needs has facilitated the reintroduction of this therapeutic option.&#xD;
&#xD;
      The EnsoETM, made by Attune Medical, received its CE mark in Europe in 2014, with an expanded&#xD;
      indicated use of up to 120 hours in 2016 and a CE mark for its use with the Altrix system by&#xD;
      Stryker® in 2017. (CE certificate attached.) The EnsoETM is used as part of treatment to&#xD;
      obtain therapeutic hypothermia during the management of a heart attack. It is also used in&#xD;
      the treatment of hyperthermia, the prevention of unexpected peri-operative hypothermia, and&#xD;
      the reduction of elevated intracranial pressure.&#xD;
&#xD;
      The device is situated in the esophagus like a standard orogastric sensor. A multi-channel&#xD;
      cylindrical silicone tube connected to a closed water circuit allows the surrounding tissue&#xD;
      to be warmed or cooled according to the need or desired temperature. This effect is achieved&#xD;
      through the transfer of heat via conduction through the esophagus and by convection through&#xD;
      the device. One must keep in mind that the posterior wall of the left atrium is in close&#xD;
      contact with the esophagus and the modular effect of the temperature therefore also acts on&#xD;
      the wall of the atrium.&#xD;
&#xD;
      The EnsoETM is designed to use the high-blood-flow surroundings of the esophagus and achieve&#xD;
      high heat-exchange performance. In addition, the EnsoETM has a distal end that reaches the&#xD;
      stomach and allows it to be decompressed, avoiding distension of the esophagus, which ensures&#xD;
      good contact between the device and the esophageal mucosa, thereby maximizing the transfer of&#xD;
      heat between the device and the patient. The EnsoETM is composed of standard medical-grade&#xD;
      silicone, and is generally similar in shape and size to gastric probes and other devices that&#xD;
      are routinely situated in the esophagus (esophagogastroduodenoscopes, transesophageal&#xD;
      echocardiogram probes, Ewald tubes, etc.). It is also smaller than other more aggressive&#xD;
      devices (the EnsoETM measures approximately 1/3 the size of the Sengstaken-Blakemore tube&#xD;
      used to treat esophageal varices).&#xD;
&#xD;
      The preliminary data available show that the use of probes that regulate the esophageal&#xD;
      temperature would allow the mucosa of thermal lesions to be protected, thereby reducing and&#xD;
      preventing lesions on this level during the fibrillation ablation treatment. However, it is&#xD;
      not known whether the modulation of esophageal temperature or contact with the atrial wall&#xD;
      affect the efficacy of the actual lesions induced on the atrium and therefore on the success&#xD;
      of the ablation procedure.&#xD;
&#xD;
      Hypothesis&#xD;
&#xD;
      General hypothesis:&#xD;
&#xD;
      Esophageal protection probes allow the deleterious effects of pulmonary vein ablation to be&#xD;
      counteracted on the wall of the esophagus.&#xD;
&#xD;
      Secondary hypotheses:&#xD;
&#xD;
      1. The incidence of esophageal lesions in our setting, in which a conservative approach is&#xD;
      applied to the ablation of pulmonary veins, is low but not insignificant.&#xD;
&#xD;
      2 The use of esophageal protection probes allows the incidence of esophageal lesions to be&#xD;
      decreased.&#xD;
&#xD;
      3 The use of esophageal protection probes does not alter the clinical result of the pulmonary&#xD;
      vein ablation procedure.&#xD;
&#xD;
      2. GENERAL AND SPECIFIC OBJECTIVES:&#xD;
&#xD;
      Main objective:&#xD;
&#xD;
      Assess the role of esophageal protection probes during pulmonary vein ablation procedures.&#xD;
&#xD;
      Secondary objectives&#xD;
&#xD;
        1. Assess the incidence of esophageal lesions in our setting.&#xD;
&#xD;
        2. Assess if the use of a probe for esophageal protection reduces the incidence of&#xD;
           esophageal lesions.&#xD;
&#xD;
        3. Assess if the use of esophageal protection probes alters the clinical result of the&#xD;
           pulmonary vein ablation procedure.&#xD;
&#xD;
      3. METHODS:&#xD;
&#xD;
      Study design&#xD;
&#xD;
      The investigators propose a prospective pilot study to assess the incidence of esophageal&#xD;
      lesions following a pulmonary vein ablation procedure in our care center in which a&#xD;
      conservative approach is used to apply the energy. In addition, in a limited number of&#xD;
      patients, the study aims to assess the effect of an esophageal protection probe on the&#xD;
      occurrence of thermal lesions and the results of the ablation.&#xD;
&#xD;
      The study protocol will be carried out under the directives of the Institutional Ethics&#xD;
      Committee in the Hospital de la Santa Creu i Sant Pau.&#xD;
&#xD;
      Patients referred for catheter ablation of atrial fibrillation (either cryoablation or&#xD;
      radiofrequency ablation (1/1)) will be randomized to either receive or not (1/1) an&#xD;
      esophageal temperature adjustment EnsoETM device, to evaluate its role for esophageal&#xD;
      protection.&#xD;
&#xD;
      Ablation procedure:&#xD;
&#xD;
      All patients included in the study will be subject to an ablation procedure following the&#xD;
      standard guidelines in our center with no modification, where the investigators carry out the&#xD;
      procedures under general anesthesia. Instead of using a conventional orogastric probe, the&#xD;
      patients in the probe-evaluation group will systematically use the probe protecting against&#xD;
      thermal lesions with no other variation.&#xD;
&#xD;
      Use of the EnsoETM esophageal probe:&#xD;
&#xD;
      Placement of the EnsoETM will follow standard recommendations according to the instructions,&#xD;
      which are similar to recommendations for inserting a transesophageal echocardiogram probe&#xD;
      (routine procedure in some centers to guide the transseptal puncture) or the orogastric&#xD;
      aspiration probe during surgical procedures. The EnsoETM will be connected to the appropriate&#xD;
      console (Meditherm, Blanketrol, or Altrix). The configuration will be adjusted according to&#xD;
      the ablation technique (cryoablation or radiofrequency ablation). If radio frequency is used,&#xD;
      before beginning the ablation of the left posterior wall, the heat exchanger connected to the&#xD;
      EnsoETM will be adjusted to a cooling mode (5°C), with ablation beginning at least 1 min&#xD;
      after the circulating water reaches a temperature of 5°C. If cryoablation is used, before&#xD;
      beginning the application, the heat exchanger connected to the EnsoETM will be adjusted to a&#xD;
      heating mode (45°C), with cryoablation beginning at least 1 min after the circulating water&#xD;
      reaches a temperature of 45°C.&#xD;
&#xD;
      Esophagogastroscopy:&#xD;
&#xD;
      An esophagogastroscopy will be done on all patients, a day later after the catheter ablation,&#xD;
      following the usual guidelines of the Gastroenterology Service. Local anesthesia will be used&#xD;
      with superficial sedation following a 12-hour fast. Basal anticoagulant treatment will be&#xD;
      maintained without any precise antibiotic prophylaxis. The gastroenterologist will provide a&#xD;
      report on the procedure, classifying the findings in agreement with Zargar's criteria,&#xD;
      assessing them qualitatively as light, moderate, or serious. Special focus will be placed on&#xD;
      the anterior zone of the esophagus at the level of the left atrium, which is where the energy&#xD;
      (radio frequency or cryoablation) is applied during the procedure.&#xD;
&#xD;
      Monitoring:&#xD;
&#xD;
      The usual treatment and controls will both be followed unless the gastroenterologist changes&#xD;
      the recommendations due to the endoscopy findings. Follow-up visits will be made at 1, 3, 6,&#xD;
      and 12 after the procedure to assess the presence of cardiological and gastrointestinal&#xD;
      symptoms.&#xD;
&#xD;
      Study population. The population will consist of patients subjected to their first pulmonary&#xD;
      vein ablation procedure in the left atrium to treat atrial fibrillation.&#xD;
&#xD;
      Definition of variables&#xD;
&#xD;
        1. Demographic variables: age, gender, weight, and height&#xD;
&#xD;
        2. Clinical variables: cardiovascular risk factors, atrial fibrillation factors (alcohol,&#xD;
           sleep apnea, obesity, …), previous atrial fibrillation arrhythmia, history of&#xD;
           gastrointestinal pathology (reflux, esophagitis, gastritis, H Pylori infection, …),&#xD;
           history of cardiological pathology (basic structural cardiomyopathy: ischemic, valvular,&#xD;
           hypertensive, diameter and volume of the left atrium, ejection fraction, …).&#xD;
&#xD;
        3. Family history of early atrial fibrillation (&lt;40 years).&#xD;
&#xD;
        4. Previous pharmacological treatment: especially anti-arrhythmia, anticoagulant and&#xD;
           anti-secretion or gastric protector (indication, dosage, time, and administration&#xD;
           route).&#xD;
&#xD;
        5. Effectiveness of pulmonary vein isolation.&#xD;
&#xD;
        6. Radio-physical variables of the ablation (number of applications, duration of&#xD;
           application, maximum or minimum temperature, power (W), ablation index per region&#xD;
           (anterior, posterior).&#xD;
&#xD;
        7. Duration of procedure: fluoroscopy, catheterization in the left atrium.&#xD;
&#xD;
        8. Clinical or electrical efficacy. Recurrence of arrhythmia (palpitations, ECG, or Holter&#xD;
           monitor)&#xD;
&#xD;
        9. Esophageal lesions per Zargar endoscopy classification&#xD;
&#xD;
       10. Adverse clinical events&#xD;
&#xD;
             -  Dysphagia: the patient relates difficulty swallowing for more than 24 hours after&#xD;
                the use of the device; diagnosed via modified barium swallow study,&#xD;
                videofluoroscopic swallow study, or related directly by the patient.&#xD;
&#xD;
             -  Odynophagia: the patient relates pain when swallowing for more than 24 hours after&#xD;
                the use of the device; diagnosed via the patient's subjective feelings.&#xD;
&#xD;
             -  Esophageal lesion not due to ablation: evidence of traumatic lesions or other&#xD;
                esophageal lesions diagnosed by a gastroenterologist.&#xD;
&#xD;
      Sample size and strength Given that the incidence of esophageal lesions in recent studies was&#xD;
      estimated to be 40-50%, and a reduction of 20% was calculated in the appearance of lesions&#xD;
      with the use of the probe compared to control conditions (without modification of the&#xD;
      esophageal temperature), with a power of 80% and an alpha error of 0.05. A necessary sample&#xD;
      size of 28 patients was specified for each of the techniques used (radio frequency and&#xD;
      cryoablation).&#xD;
&#xD;
      Method. Sources of information The information gathered throughout the study will be&#xD;
      collected in an encrypted database designed and built specifically for the study. Atrial&#xD;
      fibrillation ablation is a common technique in our center, with more than 100 procedures&#xD;
      performed annually.&#xD;
&#xD;
      Data management and analysis Statistical analysis will be carried out with the statistics&#xD;
      program SPSS, version 25.0 (IBM Corporation). The continuous variables will be expressed as&#xD;
      an average and standard variation or medians and interquartile range, depending on whether&#xD;
      the distribution is statistically different from a normal distribution. Qualitative variables&#xD;
      will be presented as numbers and percentages. To study the relationship between qualitative&#xD;
      variables, the chi-squared test (X2) will be used; Fisher's exact test will be used for&#xD;
      variables that do not follow a normal distribution. The quantitative variables will be&#xD;
      compared using Student's t-test if two groups are compared; analysis of variance (ANOVA) will&#xD;
      be used for more than two groups. If the quantitative variables do not follow a normal&#xD;
      distribution, non-parametric tests will be used: the Mann-Whitney U-test for two groups or&#xD;
      the Kruskal-Wallis test for more than two groups. The correlation between the variables will&#xD;
      be studied using the Pearson or Spearman tests, depending on whether the distribution is&#xD;
      normal or not. Differences with a p-value of 0.05 or higher will be considered significant.&#xD;
&#xD;
      The only significant change with respect to usual practice is that an upper digestive&#xD;
      endoscopy will be performed on all patients included. However, this activity is not expected&#xD;
      to lead to a change in the length of admission or in the treatment administered. Although it&#xD;
      is a new element, the introduction of the probe is not expected to lead to significant&#xD;
      changes, since all patients are intubated in the usual way and, based on need, a nasogastric&#xD;
      probe of reduced size will simultaneously be introduced in the same way as the study probe to&#xD;
      avoid gastric distension.&#xD;
&#xD;
      5. WORK PLAN (tasks, benchmarks and timeline of the study): Month 1 Development of the&#xD;
      protocol. Editing of study materials. Design of the database. Researcher meeting to resolve&#xD;
      doubts. Preparation of logistical aspects to begin the study.&#xD;
&#xD;
      Month 2 Presentation to the Research Ethics Committee. Months 3-12 Beginning of the study.&#xD;
      Dissemination of the services involved (cardiology, anesthesiology, gastroenterology). Data&#xD;
      collection and entry.&#xD;
&#xD;
      Months 12-18 Data cleaning and analysis. Researcher meeting to resolve doubts and close the&#xD;
      study. Drafting of the final report. Drafting of a manuscript to publish the results.&#xD;
&#xD;
      Duration: 18 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Anticipated">November 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients referred for catheter ablation of atrial fibrillation (either cryoablation or radiofrequency ablation (1/1)) will be randomized to either receive or not (1/1) an esophageal temperature adjustment EnsoETM device, to evaluate its role for esophageal protection.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of esophageal damage</measure>
    <time_frame>1 day</time_frame>
    <description>Presence of esophageal lesions will be determined after ablation using esophagogastroscopy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of esophageal damage</measure>
    <time_frame>1 day</time_frame>
    <description>Degree of esophageal lesions will be determined after ablation using esophagogastroscopy. Degree of esophageal lesions severity will be determined according to the Zargar endoscopy classification (0, I, IIa, IIb, IIIa, IIIb, IV)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of esophageal damage</measure>
    <time_frame>&lt;48 hours</time_frame>
    <description>Presence of esophageal lesions will be determined after ablation using magnetic resonance imaging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence of atrial fibrillation</measure>
    <time_frame>1 year</time_frame>
    <description>Recurrence of atrial fibrillation after catheter ablation will be determined in the follow-up:&#xD;
clinically, as episodes with high clinical suspicion of being atrial fibrillation despite no ECG documentation&#xD;
documented in ECG or in 24-hours holter monitoring, and defined as an episode lasting more than 30 seconds. 24-hours holter monitoring will be performed 3, 6 and 12 months after catheter ablation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Catheter Ablation</condition>
  <condition>Esophageal Fistula</condition>
  <condition>Esophageal Diseases</condition>
  <condition>Arrhythmias, Cardiac</condition>
  <arm_group>
    <arm_group_label>Non esophageal protection</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this group will undergo a first atrial fibrillation catheter ablation procedure with pulmonary vein isolation to study esophageal lesions. The esophageal protection probe will not be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Esophageal protection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will undergo a first atrial fibrillation catheter ablation procedure with pulmonary vein isolation, using the esophageal protection probe EnsoETM</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EnsoETM</intervention_name>
    <description>The EnsoETM is a device with a esophageal probe that can provide temperature adjustment</description>
    <arm_group_label>Esophageal protection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (older than 18 years of age) subjected to their first pulmonary vein&#xD;
             isolation procedure with a catheter or balloon.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known esophageal deformity or evidence of esophageal trauma (for&#xD;
             example, history of esophagectomy, previous swallowing disorders, achalasia, etc.)&#xD;
&#xD;
          -  Patients with known ingestion of acidic or caustic poison in the previous 24 hours.&#xD;
&#xD;
          -  Patients weighing less than 40 kg.&#xD;
&#xD;
          -  Patients who know they are pregnant.&#xD;
&#xD;
          -  Patients under chronic daily treatment with an proton pump inhibitor or any&#xD;
             gastrointestinal acid suppressant.&#xD;
&#xD;
          -  Patients under 18 years of age.&#xD;
&#xD;
          -  Patients who have not signed the informed consent form.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose Maria Guerra Ramos, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bieito Campos Garcia, MD</last_name>
    <phone>+34935565850</phone>
    <email>bcamposg@santpau.cat</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bieito Campos Garcia, MD</last_name>
      <phone>+345565850</phone>
      <email>bcamposg@santpau.cat</email>
    </contact>
    <investigator>
      <last_name>Jose Maria Guerra Ramos, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bieito Campos Garcia, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Enrique Rodríguez Font, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Concepción Alonso Martín, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xavier Viñolas Prat, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maite Rivilla Lozano, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cristina Gómez Oliva, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Tzou WS, Russo AM. Luminal esophageal temperature monitoring for the prevention of esophageal injury during left atrial ablation: LET it be? J Cardiovasc Electrophysiol. 2013 Sep;24(9):965-7. doi: 10.1111/jce.12198. Epub 2013 Jul 19. No abstract available.</citation>
    <PMID>23869691</PMID>
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  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>March 27, 2019</last_update_submitted>
  <last_update_submitted_qc>March 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Diseases</mesh_term>
    <mesh_term>Esophageal Fistula</mesh_term>
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no IPD sharing plan</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03832959
org study id: IIBSP-ABL-2018-55
nct id: NCT03832959
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Catheter ablation of atrial fibrillation with electrical isolation of the pulmonary veins in
      the left atrium carries risk of esophagus thermal lesion. EnsoETM is a device . This study
      evaluates the benefit of using the EnsoETM, a device device for esophageal temperature
      adjustments, during catheter ablation of atrial fibrillation. Half of participants will
      undergo esophageal temperature adjustment during pulmonary vein catheter ablation, while the
      other half will undergo catheter ablation with no esophageal temperature adjustment.
1. THEORETICAL FRAMEWORK. APPROACH TO THE PROBLEM

      Background and justification

      Atrial fibrillation is the most common type of heart arrhythmia. Electrical isolation of the
      pulmonary veins in the left atrium with ablation is standard therapy in the invasive
      treatment of atrial fibrillation. One of the risks of this intervention is thermal lesion of
      the esophagus, since it is in contact with the posterior wall of the left atrium. The energy
      applied for electrical isolation via either radiofrequency or cryotherapy can cause thermal
      lesions due to proximity with the esophagus and the vagus nerve/parasympathetic nervous
      system of the upper digestive tract. The incidence is not well established and data in the
      existing scarce publications show a very wide range, from 3 to 60%, according to the
      definition and means of the study used. The most recent systematic studies show values around
      40-50%. The lesions observed vary in degree, from erythema or minor erosion to ulcers of the
      esophageal mucosa, including local hematomas, spasms, and esophageal/gastric motility
      disorders and even atrial-esophageal fistula, the extreme consequence of thermal esophageal
      lesion; the incidence of the latter is low (0.25%), but it has an elevated mortality. The
      best examination to diagnose and evaluate these lesions in all phases is upper digestive
      endoscopy or fibro esophagogastroscopy. Although it is routine in digestive services
      throughout the world, enabling the direct visualization and characterization of lesions, this
      technique is not performed systematically after ablation procedures, which explains the
      contradictory data in the literature.

      Likewise, the possible long-term consequences of minor lesions are unknown, which, in a large
      number of patients are totally asymptomatic. For this reason, it cannot be ignored that acute
      tissue damage, however minimal, could lead to future changes in the form of late onset
      chronic esophageal pathology. The incidence and magnitude of esophageal involvement has been
      directly related to the ablation technique and protocol. Most available studies have been
      carried out in centers with ablation protocols that are significantly more aggressive than
      those used in our care facility. For this reason, the investigators do not have reliable data
      regarding the size of the problem in our center, which could present some differential
      characteristics.

      To date, the prevention of these esophageal lesions has entailed: limits in the energy
      applied on the posterior wall of the left atrium (less power or shorter application time);
      monitoring of the luminal esophageal temperature during radio frequency or cryotherapy
      applications; stopping application early if certain temperatures considered risky were
      reached. However, the success of luminal esophageal temperature monitoring in preventing
      lesions varies widely, given that the temperature probes are very thin with respect to the
      total diameter of the esophagus, their position varies with respect to the cardiac tissue
      treated, and contact with the esophageal mucosa is inconstant. In fact, it has been reported
      that the temperature probes used for monitoring can contribute to increasing thermal lesions,
      given that their metal elements can boost direct heating/cooling of the tissue and make the
      lesion larger and last longer. In fact, the incidence of esophageal lesions is very similar,
      independent of the use of the temperature probe, or if it is a single or multi-sensor.
      Another controversial aspect of these temperature probes is that their use can lead to - at
      least potentially and in pursuit of safety - shorter, limited applications, which could cause
      incomplete non-transmural lesions and hamper the correct treatment of patients, thereby
      becoming a factor that increases the recurrence of atrial fibrillation. In addition, these
      probes should be deployed during the procedure so they are as close as possible to the
      application site (right or left veins depending on the time), which increases the procedure
      and fluoroscopy time, with consequent risks for both the patient and the medical team. All
      these limitations, together with significant economic cost overruns have meant that the use
      of this approach in our care facilities has been minimal and only for research purposes.

      Even if the possible long-term consequences of esophageal lesions are minimal, studying new
      strategies for esophageal protection that are easy to implement and do not affect the
      efficacy of ablation procedures is of great clinical and scientific interest. In this
      context, there is a plan to use the probes to regulate and maintain patient temperature in
      prolonged surgeries or critical units as a method of esophageal protection during ablation.
      Multiple clinical studies have demonstrated the efficacy and safety of these probes in
      different medical/surgical areas. In particular, they are indicated to minimize the
      neurological damage associated with heart attacks through the induction of therapeutic
      hypothermia. They are also indicated to reduce the temperature of patients with malignant
      hyperthermia, to prevent unexpected peri-operative hypothermia, and to reduce elevated
      intracranial pressure.

      The prevention of esophageal lesions via temperature control (local cooling of the esophagus
      when radiofrequency is used or heating when cryotherapy is used, thanks to various probe
      configurations) has been investigated with mathematical models, preclinical models, and in
      the clinical field in a preliminary way. Data are available that demonstrate its efficacy in
      this approach, although with limitations in the number of cases and the systems used. In most
      of these studies, prototypes of anterior probes were used, which are difficult to place and
      require changes in the work routine, which has made the expansion of devices using this
      approach more difficult up to now.

      The appearance of a new, easier-to-use device for esophageal temperature adjustments
      (EnsoETM, Attune Medical, Chicago, Illinois, USA) when managing patient temperature for a
      large variety of needs has facilitated the reintroduction of this therapeutic option.

      The EnsoETM, made by Attune Medical, received its CE mark in Europe in 2014, with an expanded
      indicated use of up to 120 hours in 2016 and a CE mark for its use with the Altrix system by
      Stryker® in 2017. (CE certificate attached.) The EnsoETM is used as part of treatment to
      obtain therapeutic hypothermia during the management of a heart attack. It is also used in
      the treatment of hyperthermia, the prevention of unexpected peri-operative hypothermia, and
      the reduction of elevated intracranial pressure.

      The device is situated in the esophagus like a standard orogastric sensor. A multi-channel
      cylindrical silicone tube connected to a closed water circuit allows the surrounding tissue
      to be warmed or cooled according to the need or desired temperature. This effect is achieved
      through the transfer of heat via conduction through the esophagus and by convection through
      the device. One must keep in mind that the posterior wall of the left atrium is in close
      contact with the esophagus and the modular effect of the temperature therefore also acts on
      the wall of the atrium.

      The EnsoETM is designed to use the high-blood-flow surroundings of the esophagus and achieve
      high heat-exchange performance. In addition, the EnsoETM has a distal end that reaches the
      stomach and allows it to be decompressed, avoiding distension of the esophagus, which ensures
      good contact between the device and the esophageal mucosa, thereby maximizing the transfer of
      heat between the device and the patient. The EnsoETM is composed of standard medical-grade
      silicone, and is generally similar in shape and size to gastric probes and other devices that
      are routinely situated in the esophagus (esophagogastroduodenoscopes, transesophageal
      echocardiogram probes, Ewald tubes, etc.). It is also smaller than other more aggressive
      devices (the EnsoETM measures approximately 1/3 the size of the Sengstaken-Blakemore tube
      used to treat esophageal varices).

      The preliminary data available show that the use of probes that regulate the esophageal
      temperature would allow the mucosa of thermal lesions to be protected, thereby reducing and
      preventing lesions on this level during the fibrillation ablation treatment. However, it is
      not known whether the modulation of esophageal temperature or contact with the atrial wall
      affect the efficacy of the actual lesions induced on the atrium and therefore on the success
      of the ablation procedure.

      Hypothesis

      General hypothesis:

      Esophageal protection probes allow the deleterious effects of pulmonary vein ablation to be
      counteracted on the wall of the esophagus.

      Secondary hypotheses:

      1. The incidence of esophageal lesions in our setting, in which a conservative approach is
      applied to the ablation of pulmonary veins, is low but not insignificant.

      2 The use of esophageal protection probes allows the incidence of esophageal lesions to be
      decreased.

      3 The use of esophageal protection probes does not alter the clinical result of the pulmonary
      vein ablation procedure.

      2. GENERAL AND SPECIFIC OBJECTIVES:

      Main objective:

      Assess the role of esophageal protection probes during pulmonary vein ablation procedures.

      Secondary objectives

        1. Assess the incidence of esophageal lesions in our setting.

        2. Assess if the use of a probe for esophageal protection reduces the incidence of
           esophageal lesions.

        3. Assess if the use of esophageal protection probes alters the clinical result of the
           pulmonary vein ablation procedure.

      3. METHODS:

      Study design

      The investigators propose a prospective pilot study to assess the incidence of esophageal
      lesions following a pulmonary vein ablation procedure in our care center in which a
      conservative approach is used to apply the energy. In addition, in a limited number of
      patients, the study aims to assess the effect of an esophageal protection probe on the
      occurrence of thermal lesions and the results of the ablation.

      The study protocol will be carried out under the directives of the Institutional Ethics
      Committee in the Hospital de la Santa Creu i Sant Pau.

      Patients referred for catheter ablation of atrial fibrillation (either cryoablation or
      radiofrequency ablation (1/1)) will be randomized to either receive or not (1/1) an
      esophageal temperature adjustment EnsoETM device, to evaluate its role for esophageal
      protection.

      Ablation procedure:

      All patients included in the study will be subject to an ablation procedure following the
      standard guidelines in our center with no modification, where the investigators carry out the
      procedures under general anesthesia. Instead of using a conventional orogastric probe, the
      patients in the probe-evaluation group will systematically use the probe protecting against
      thermal lesions with no other variation.

      Use of the EnsoETM esophageal probe:

      Placement of the EnsoETM will follow standard recommendations according to the instructions,
      which are similar to recommendations for inserting a transesophageal echocardiogram probe
      (routine procedure in some centers to guide the transseptal puncture) or the orogastric
      aspiration probe during surgical procedures. The EnsoETM will be connected to the appropriate
      console (Meditherm, Blanketrol, or Altrix). The configuration will be adjusted according to
      the ablation technique (cryoablation or radiofrequency ablation). If radio frequency is used,
      before beginning the ablation of the left posterior wall, the heat exchanger connected to the
      EnsoETM will be adjusted to a cooling mode (5°C), with ablation beginning at least 1 min
      after the circulating water reaches a temperature of 5°C. If cryoablation is used, before
      beginning the application, the heat exchanger connected to the EnsoETM will be adjusted to a
      heating mode (45°C), with cryoablation beginning at least 1 min after the circulating water
      reaches a temperature of 45°C.

      Esophagogastroscopy:

      An esophagogastroscopy will be done on all patients, a day later after the catheter ablation,
      following the usual guidelines of the Gastroenterology Service. Local anesthesia will be used
      with superficial sedation following a 12-hour fast. Basal anticoagulant treatment will be
      maintained without any precise antibiotic prophylaxis. The gastroenterologist will provide a
      report on the procedure, classifying the findings in agreement with Zargar's criteria,
      assessing them qualitatively as light, moderate, or serious. Special focus will be placed on
      the anterior zone of the esophagus at the level of the left atrium, which is where the energy
      (radio frequency or cryoablation) is applied during the procedure.

      Monitoring:

      The usual treatment and controls will both be followed unless the gastroenterologist changes
      the recommendations due to the endoscopy findings. Follow-up visits will be made at 1, 3, 6,
      and 12 after the procedure to assess the presence of cardiological and gastrointestinal
      symptoms.

      Study population. The population will consist of patients subjected to their first pulmonary
      vein ablation procedure in the left atrium to treat atrial fibrillation.

      Definition of variables

        1. Demographic variables: age, gender, weight, and height

        2. Clinical variables: cardiovascular risk factors, atrial fibrillation factors (alcohol,
           sleep apnea, obesity, …), previous atrial fibrillation arrhythmia, history of
           gastrointestinal pathology (reflux, esophagitis, gastritis, H Pylori infection, …),
           history of cardiological pathology (basic structural cardiomyopathy: ischemic, valvular,
           hypertensive, diameter and volume of the left atrium, ejection fraction, …).

        3. Family history of early atrial fibrillation (<40 years).

        4. Previous pharmacological treatment: especially anti-arrhythmia, anticoagulant and
           anti-secretion or gastric protector (indication, dosage, time, and administration
           route).

        5. Effectiveness of pulmonary vein isolation.

        6. Radio-physical variables of the ablation (number of applications, duration of
           application, maximum or minimum temperature, power (W), ablation index per region
           (anterior, posterior).

        7. Duration of procedure: fluoroscopy, catheterization in the left atrium.

        8. Clinical or electrical efficacy. Recurrence of arrhythmia (palpitations, ECG, or Holter
           monitor)

        9. Esophageal lesions per Zargar endoscopy classification

       10. Adverse clinical events

             -  Dysphagia: the patient relates difficulty swallowing for more than 24 hours after
                the use of the device; diagnosed via modified barium swallow study,
                videofluoroscopic swallow study, or related directly by the patient.

             -  Odynophagia: the patient relates pain when swallowing for more than 24 hours after
                the use of the device; diagnosed via the patient's subjective feelings.

             -  Esophageal lesion not due to ablation: evidence of traumatic lesions or other
                esophageal lesions diagnosed by a gastroenterologist.

      Sample size and strength Given that the incidence of esophageal lesions in recent studies was
      estimated to be 40-50%, and a reduction of 20% was calculated in the appearance of lesions
      with the use of the probe compared to control conditions (without modification of the
      esophageal temperature), with a power of 80% and an alpha error of 0.05. A necessary sample
      size of 28 patients was specified for each of the techniques used (radio frequency and
      cryoablation).

      Method. Sources of information The information gathered throughout the study will be
      collected in an encrypted database designed and built specifically for the study. Atrial
      fibrillation ablation is a common technique in our center, with more than 100 procedures
      performed annually.

      Data management and analysis Statistical analysis will be carried out with the statistics
      program SPSS, version 25.0 (IBM Corporation). The continuous variables will be expressed as
      an average and standard variation or medians and interquartile range, depending on whether
      the distribution is statistically different from a normal distribution. Qualitative variables
      will be presented as numbers and percentages. To study the relationship between qualitative
      variables, the chi-squared test (X2) will be used; Fisher's exact test will be used for
      variables that do not follow a normal distribution. The quantitative variables will be
      compared using Student's t-test if two groups are compared; analysis of variance (ANOVA) will
      be used for more than two groups. If the quantitative variables do not follow a normal
      distribution, non-parametric tests will be used: the Mann-Whitney U-test for two groups or
      the Kruskal-Wallis test for more than two groups. The correlation between the variables will
      be studied using the Pearson or Spearman tests, depending on whether the distribution is
      normal or not. Differences with a p-value of 0.05 or higher will be considered significant.

      The only significant change with respect to usual practice is that an upper digestive
      endoscopy will be performed on all patients included. However, this activity is not expected
      to lead to a change in the length of admission or in the treatment administered. Although it
      is a new element, the introduction of the probe is not expected to lead to significant
      changes, since all patients are intubated in the usual way and, based on need, a nasogastric
      probe of reduced size will simultaneously be introduced in the same way as the study probe to
      avoid gastric distension.

      5. WORK PLAN (tasks, benchmarks and timeline of the study): Month 1 Development of the
      protocol. Editing of study materials. Design of the database. Researcher meeting to resolve
      doubts. Preparation of logistical aspects to begin the study.

      Month 2 Presentation to the Research Ethics Committee. Months 3-12 Beginning of the study.
      Dissemination of the services involved (cardiology, anesthesiology, gastroenterology). Data
      collection and entry.

      Months 12-18 Data cleaning and analysis. Researcher meeting to resolve doubts and close the
      study. Drafting of the final report. Drafting of a manuscript to publish the results.

      Duration: 18 months
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients referred for catheter ablation of atrial fibrillation (either cryoablation or radiofrequency ablation (1/1)) will be randomized to either receive or not (1/1) an esophageal temperature adjustment EnsoETM device, to evaluate its role for esophageal protection.
primary purpose: Treatment
masking: None (Open Label)
measure: Presence of esophageal damage
time frame: 1 day
description: Presence of esophageal lesions will be determined after ablation using esophagogastroscopy.
measure: Severity of esophageal damage
time frame: 1 day
description: Degree of esophageal lesions will be determined after ablation using esophagogastroscopy. Degree of esophageal lesions severity will be determined according to the Zargar endoscopy classification (0, I, IIa, IIb, IIIa, IIIb, IV)
measure: Presence of esophageal damage
time frame: <48 hours
description: Presence of esophageal lesions will be determined after ablation using magnetic resonance imaging
measure: Recurrence of atrial fibrillation
time frame: 1 year
description: Recurrence of atrial fibrillation after catheter ablation will be determined in the follow-up:
clinically, as episodes with high clinical suspicion of being atrial fibrillation despite no ECG documentation
documented in ECG or in 24-hours holter monitoring, and defined as an episode lasting more than 30 seconds. 24-hours holter monitoring will be performed 3, 6 and 12 months after catheter ablation
arm group label: Non esophageal protection
arm group type: No Intervention
description: Patients in this group will undergo a first atrial fibrillation catheter ablation procedure with pulmonary vein isolation to study esophageal lesions. The esophageal protection probe will not be used.
arm group label: Esophageal protection
arm group type: Experimental
description: Patients in this group will undergo a first atrial fibrillation catheter ablation procedure with pulmonary vein isolation, using the esophageal protection probe EnsoETM
intervention type: Device
intervention name: EnsoETM
description: The EnsoETM is a device with a esophageal probe that can provide temperature adjustment
arm group label: Esophageal protection
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jose Maria Guerra Ramos, MD PhD
role: Principal Investigator
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
last name: Bieito Campos Garcia, MD
phone: +34935565850
email: bcamposg@santpau.cat
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Spain
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responsible party type: Sponsor
mesh term: Esophageal Diseases
mesh term: Esophageal Fistula
mesh term: Atrial Fibrillation
mesh term: Arrhythmias, Cardiac
mesh term: Fistula
sharing ipd: No
ipd description: There is no IPD sharing plan