xml: <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/NCT06026683</url>
    </required_header>
    <id_info>
      <org_study_id>STAY trial</org_study_id>
      <nct_id>NCT06026683</nct_id>
    </id_info>
    <brief_title>Conduction System Stimulation to Avoid Left Ventricle Dysfunction</brief_title>
    <acronym>STAY</acronym>
    <official_title>Conduction System Stimulation to Avoid Left Ventricle Dysfunction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Parc de Salut Mar</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Parc de Salut Mar</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>
        The aim of the study is to demonstrate that conduction system pacing (CSP) can preserve a&#xD;
        normal ventricular function compared to right ventricular apical pacing (RVAP) in patients&#xD;
        with pre-implant preserved left ventricular ejection fraction (LVEF) and a high burden of&#xD;
        expected ventricular pacing due to atrioventricular conduction block (AV block).&#xD;
  &#xD;
        After informed consent signature, patients with high degree AV block and normal LVEF will be&#xD;
        randomized to permanent pacemaker stimulation with CSP vs RVAP.&#xD;
  &#xD;
        All the patients have a complete evaluation before the procedure and at 3 and 6 months&#xD;
        follow-up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The STAY trial (Conduction System sTimulation to Avoid left ventricle dYsfunction) is a&#xD;
        single-center, prospective, randomized, parallel, controlled study, comparing mid-term&#xD;
        outcomes in a population undergoing pacemaker implantation due to a high degree&#xD;
        atrio-ventricular block (AVB). The study was approved by the Hospital Ethics Committee, in&#xD;
        accordance with the Declaration of Helsinki. All patients signed informed consent and were&#xD;
        implanted between September 2019 until December 2022 in a 1:1 randomized fashion to&#xD;
        conventional RVAP vs CSP (HBS or LBBS). Randomization was performed during the pre-procedural&#xD;
        antibiotic infusion.&#xD;
  &#xD;
        All the patients have a complete evaluation before the procedure and at 3 and 6 months&#xD;
        follow-up, including demographic and clinical characteristics, physical examination,&#xD;
        twelve-lead ECG, Minnesota score (MLWHFQ), and blood test with NT-ProBNP determination.&#xD;
        Patients also have a transthoracic echography before the procedure and at 6 months follow-up.&#xD;
  &#xD;
        At 6 months echocardiographic and clinical data will be compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">September 30, 2019</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Actual">June 2, 2023</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 will be randomized into 2 groups according to pacing site: CSP vs RVAP.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The study is blinded for the patient and for the echocardiographers.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Delta-LVEF at 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Change in LVEF in each group at 6 months vs baseline LVEF</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Delta-LVEDD at 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Change in Left ventricular end diastolic diameter (LVEDD) in each group at 6 months vs baseline LVEDD</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delta-MLWHFQ (Minnesota score) at 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Change in MLWHFQ score in each group at 6 months vs baseline MLWHFQ score. The MLWHFQ score is obtained by using a questionnaire of 21 aspects. It depicts how heart failure affected the daily life of the patients during the last month previous to the questionnaire. Each question can be scored from 0 (&quot;No&quot; effect) to 5 (&quot;Very much&quot; effect)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delta-New York Heart Association (NYHA) class at 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Change in NYHA class in each group at 6 months vs baseline NYHA class. NYHA class places patients in one of four categories based on limitations of physical activity:&#xD;
  I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.&#xD;
  II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.&#xD;
  III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.&#xD;
  IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delta-NTProBNP at 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Change in NTProBNP levels in each group at 6 months vs baseline NTProBNP levels</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmissions due to heart failure</measure>
      <time_frame>6 months</time_frame>
      <description>Number of readmissions due to heart failure in each group during follow-up</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>New onset Atrial fibrillation</measure>
      <time_frame>6 months</time_frame>
      <description>Number of new-onset atrial fibrillation episodes in each group during follow-up</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <time_frame>6 months</time_frame>
      <description>All-cause Mortality in each group during follow-up</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">75</enrollment>
    <condition>Atrioventricular Block, Second and Third Degree</condition>
    <condition>Pacemaker-Induced Cardiomyopathy</condition>
    <condition>Heart Failure</condition>
    <arm_group>
      <arm_group_label>CSP (Conduction system pacing)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients with pacemaker implanted with conduction system pacing.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>RVAP (Right ventricular apical pacing)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients with pacemaker implanted with right ventricular apical pacing.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Pacemaker implant</intervention_name>
      <description>Implantation of pacemaker with conduction system pacing or right ventricular apical pacing</description>
      <arm_group_label>CSP (Conduction system pacing)</arm_group_label>
      <arm_group_label>RVAP (Right ventricular apical pacing)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            1. Age of 18 years or more&#xD;
  &#xD;
            2. Preserved or mild deteriorated LVEF (Simpson &gt;40%) assessed by a recent (&lt;1 month&#xD;
               before implantation) transthoracic echocardiography.&#xD;
  &#xD;
            3. Indication for pacing based on the presence of a high degree AVB, and consequently&#xD;
               with an anticipated high burden of ventricular pacing (&gt;50%).&#xD;
  &#xD;
            4. Live expectancy of more than 6 months and capability to understand the protocol,&#xD;
               signing the informed consent form and accomplish the follow-up.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Indication for implantable cardioverter defibrillator device.&#xD;
  &#xD;
            2. Patients with previous LVD and a recovered LVEF&#xD;
  &#xD;
            3. History of myocardial infarction/revascularization or cardiac surgery within 6 months&#xD;
               before randomization&#xD;
  &#xD;
            4. Pregnancy, active cancer treatment, or participation in another clinical trial with&#xD;
               active treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ermengol Vallès, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Parc de Salut Mar</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Carlos González, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Parc de Salut Mar. Universitat Autónoma de Barcelona.</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hospital del Mar</name>
        <address>
          <city>Barcelona</city>
          <zip>08003</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Parc de Salut Mar</investigator_affiliation>
      <investigator_full_name>Ermengol Vallès</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiomyopathies</mesh_term>
      <mesh_term>Atrioventricular Block</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data will only be available upon reasonable request.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026683
  org study id: STAY trial
  nct id: NCT06026683
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The aim of the study is to demonstrate that conduction system pacing (CSP) can preserve a
        normal ventricular function compared to right ventricular apical pacing (RVAP) in patients
        with pre-implant preserved left ventricular ejection fraction (LVEF) and a high burden of
        expected ventricular pacing due to atrioventricular conduction block (AV block).
  
        After informed consent signature, patients with high degree AV block and normal LVEF will be
        randomized to permanent pacemaker stimulation with CSP vs RVAP.
  
        All the patients have a complete evaluation before the procedure and at 3 and 6 months
        follow-up.
  The STAY trial (Conduction System sTimulation to Avoid left ventricle dYsfunction) is a
        single-center, prospective, randomized, parallel, controlled study, comparing mid-term
        outcomes in a population undergoing pacemaker implantation due to a high degree
        atrio-ventricular block (AVB). The study was approved by the Hospital Ethics Committee, in
        accordance with the Declaration of Helsinki. All patients signed informed consent and were
        implanted between September 2019 until December 2022 in a 1:1 randomized fashion to
        conventional RVAP vs CSP (HBS or LBBS). Randomization was performed during the pre-procedural
        antibiotic infusion.
  
        All the patients have a complete evaluation before the procedure and at 3 and 6 months
        follow-up, including demographic and clinical characteristics, physical examination,
        twelve-lead ECG, Minnesota score (MLWHFQ), and blood test with NT-ProBNP determination.
        Patients also have a transthoracic echography before the procedure and at 6 months follow-up.
  
        At 6 months echocardiographic and clinical data will be compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be randomized into 2 groups according to pacing site: CSP vs RVAP.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: The study is blinded for the patient and for the echocardiographers.
  measure: Delta-LVEF at 6 months
  time frame: 6 months
  description: Change in LVEF in each group at 6 months vs baseline LVEF
  measure: Delta-LVEDD at 6 months
  time frame: 6 months
  description: Change in Left ventricular end diastolic diameter (LVEDD) in each group at 6 months vs baseline LVEDD
  measure: Delta-MLWHFQ (Minnesota score) at 6 months
  time frame: 6 months
  description: Change in MLWHFQ score in each group at 6 months vs baseline MLWHFQ score. The MLWHFQ score is obtained by using a questionnaire of 21 aspects. It depicts how heart failure affected the daily life of the patients during the last month previous to the questionnaire. Each question can be scored from 0 ("No" effect) to 5 ("Very much" effect)
  measure: Delta-New York Heart Association (NYHA) class at 6 months
  time frame: 6 months
  description: Change in NYHA class in each group at 6 months vs baseline NYHA class. NYHA class places patients in one of four categories based on limitations of physical activity:
  I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.
  II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.
  III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.
  IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.
  measure: Delta-NTProBNP at 6 months
  time frame: 6 months
  description: Change in NTProBNP levels in each group at 6 months vs baseline NTProBNP levels
  measure: Readmissions due to heart failure
  time frame: 6 months
  description: Number of readmissions due to heart failure in each group during follow-up
  measure: New onset Atrial fibrillation
  time frame: 6 months
  description: Number of new-onset atrial fibrillation episodes in each group during follow-up
  measure: Mortality
  time frame: 6 months
  description: All-cause Mortality in each group during follow-up
  arm group label: CSP (Conduction system pacing)
  arm group type: Active Comparator
  description: Patients with pacemaker implanted with conduction system pacing.
  arm group label: RVAP (Right ventricular apical pacing)
  arm group type: Active Comparator
  description: Patients with pacemaker implanted with right ventricular apical pacing.
  intervention type: Device
  intervention name: Pacemaker implant
  description: Implantation of pacemaker with conduction system pacing or right ventricular apical pacing
  arm group label: CSP (Conduction system pacing)
  arm group label: RVAP (Right ventricular apical pacing)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ermengol Vallès, PhD
  role: Study Director
  affiliation: Parc de Salut Mar
  last name: Carlos González, M.D.
  role: Principal Investigator
  affiliation: Parc de Salut Mar. Universitat Autónoma de Barcelona.
  facility: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Parc de Salut Mar
  investigator full name: Ermengol Vallès
  investigator title: Principal investigator
  mesh term: Cardiomyopathies
  mesh term: Atrioventricular Block
  sharing ipd: No
  ipd description: Data will only be available upon reasonable request.