<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/NCT03277976</url>
  </required_header>
  <id_info>
    <org_study_id>AIR Study</org_study_id>
    <nct_id>NCT03277976</nct_id>
  </id_info>
  <brief_title>Pulmonary Vein Isolation Guided by Ablation Index (Ablation Index Registry Study)</brief_title>
  <acronym>AIR</acronym>
  <official_title>Pulmonary Vein Isolation Guided by Ablation Index</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinica Mediterranea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinica Mediterranea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-center, research study designed to evaluate the acute&#xD;
      achievement of pulmonary vein (PV) isolation with ThermoCool SmartTouch (ST) and ThermoCool&#xD;
      SmartTouch SF (STSF) catheter using the Ablation Index Module.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center, research study designed to evaluate the acute&#xD;
      achievement of pulmonary vein (PV) isolation with ThermoCool SmartTouch (ST) and ThermoCool&#xD;
      SmartTouch SF (STSF) catheter using the Ablation Index Module.&#xD;
&#xD;
      Subjects with paroxysmal and persistent atrial fibrillation (AF) will undergo catheter&#xD;
      ablation using commercially approved devices (mapping system and catheters).&#xD;
&#xD;
      Patients will be followed up for 12 months to measure the recurrence of AF. This study is&#xD;
      expected to start in September 2017 and to continue for approximately 26 months. It is&#xD;
      anticipated that this study will require approximately 12 months for subject enrollment.&#xD;
      Patients will be followed up for at least 12 months. Data analysis is expected to require&#xD;
      approximately 2 months. At least 320 consecutive patients will be enrolled in the study&#xD;
      centers. Patients will be divided in 4 groups and enrollment will stop when at least 80&#xD;
      patients will be enrolled in each group. The investigators evaluate two ablation catheters&#xD;
      (ST and STSF) and two different ablation index settings (380 posterior - 500 anterior and 330&#xD;
      posterior - 450 anterior). Given that the rate of PV isolation with a standard wide antral&#xD;
      circumferential ablation technique (WACA) is about 70%, the investigators want to test if one&#xD;
      of two catheters or one of ablation index settings can increase the PV isolation rate of at&#xD;
      least 10% (from 70% to 80%, 95% CI 75-85%).&#xD;
&#xD;
      Primary endpoint The primary objective of this study is to evaluate which ablation strategy&#xD;
      increase the rate of WACA PV isolation, validated by mean of LASSO catheter, after first&#xD;
      encirclement, from 70% to 80%.&#xD;
&#xD;
      Secondary endpoints Incidence of early PV reconnection 30 minutes after acute PV isolation.&#xD;
      Difference in procedural and fluoroscopy time between the two groups. Incidence of AF&#xD;
      recurrence during the blanking period (3-months after ablation).&#xD;
&#xD;
      Safety of the ablation procedure. At least 320 patients undergoing catheter ablation for&#xD;
      paroxysmal or persistent AF will be enrolled.&#xD;
&#xD;
      Inclusion Criteria The following criteria must be met for subjects to be eligible for&#xD;
      inclusion into the study Subject is indicated for catheter ablation for paroxysmal AF Subject&#xD;
      is &gt; 18 years old Subject is &lt; 80 years old Subject is on adequate anticoagulation therapy&#xD;
&#xD;
      Exclusion Criteria The following criteria are exclusions for study participation Patients who&#xD;
      had already undergo an AF ablation procedure Patients with left ventricular ejection fraction&#xD;
      &lt; 35% Women of childbearing potential who are or might be pregnant Hematological&#xD;
      contraindications to ionizing radiation exposure Presence of complex congenital heart&#xD;
      disease, and cardiac surgery within 1 month from enrollment&#xD;
&#xD;
      Patients will be screened in ambulatory and scheduled for AF ablation according to current&#xD;
      guide lines. Ablation will be usually performed under effective oral anticoagulation.&#xD;
      Anticoagulation could be withdrawn before admission, so as antiarrhythmic drugs will be&#xD;
      removed before scheduled procedure. Patients in AF or with a CHA2DS2-VASc score ≥ 1 will&#xD;
      undergo transesophageal echocardiography within 48 hours prior to the ablation. For all other&#xD;
      patients transesophageal echocardiography is optional. Cardiac MRI or Cardiac CT scan could&#xD;
      be executed as a reference for volume estimations obtained with the mapping system.&#xD;
&#xD;
      Ablation will be carried out under mild or conscious sedation, at least 2 femoral vein access&#xD;
      will be obtained and in some patients 1 subclavian vein. One diagnostic catheter will be&#xD;
      positioned in the coronary sinus. One or two transseptal accesses to the left atrium will be&#xD;
      achieved using a standard approach. Then, the LASSO catheter and the ablation catheter (ST&#xD;
      and STSF) will be placed in the left atrium. Heparin will be administered before the&#xD;
      transseptal punctures to maintain an activated clotting time ≥ 300 seconds for the duration&#xD;
      of the procedure. Left atrium mapping will be performed in sinus rhythm. Patients with atrial&#xD;
      fibrillation at the beginning of the index procedure will undergo electrical cardioversion.&#xD;
      After left atrium reconstruction the effective PV-left atrium electrical connection will be&#xD;
      checked with LASSO. In all groups a wide antrum circumferential ablation aimed at PV&#xD;
      isolation will be performed using contact force threshold range between 5-40 g (14), and the&#xD;
      Ablation Index Module, with the following preset: respiration adjustment; stability range 3&#xD;
      mm, stability time 3 sec, force over time 25% of time, 3 g and ablation index thresholds: 500&#xD;
      for anterior wall and 380 for posterior wall or 450 for anterior wall and 330 for posterior&#xD;
      wall; contiguity lesion 5-6 mm (15-16). The default power setting will be 30 W, with ranges&#xD;
      of 20-40 W. At the end of the ablation effective PV isolation (entry and exit block), will be&#xD;
      checked with LASSO catheter. After PV isolation will be achieved, the reconnection of the&#xD;
      same vein will be evaluated after a 30 minute period from the initial isolation or after&#xD;
      adenosine infusion or isoproterenol. If the vein reconnects to the atrium, the ablation will&#xD;
      be directed to the gaps identified by the LASSO catheter. All patients will undergo a&#xD;
      post-procedural ECG and, optional, an echocardiogram to exclude pericardial effusion or other&#xD;
      acute complications. After ablation, patients will undertake regular follow-up assessments&#xD;
      (scheduled at 3 months) including a detailed history, physical examination, 12-lead standard&#xD;
      electrocardiography, and 24-h Holter monitoring. Patients who will not report any symptoms&#xD;
      related to the previous arrhythmia during a supplementary detailed follow up (6-12 months&#xD;
      subsequent to catheter ablation) will be considered free of arrhythmia recurrence&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 29, 2017</start_date>
  <completion_date type="Anticipated">November 28, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 28, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>The primary objective of this study is to evaluate which ablation strategy increase the rate of WACA PV isolation, validated by mean of LASSO catheter, after first encirclement, from 70% to 80%.</measure>
    <time_frame>From the end of the WACA PV isolation up to 5 min after</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of early PV reconnection 30 minutes after acute PV isolation.</measure>
    <time_frame>Up to 30 min after the effective pulmonary vein isolation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in procedural and fluoroscopy time between the two groups</measure>
    <time_frame>From the beginning of the index procedure to the end of index procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of AF recurrence during the blanking period</measure>
    <time_frame>Up to 3 months after the ablation procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-emergent adverse events.</measure>
    <time_frame>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, from the index procedure to one-year follow-up</time_frame>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">490</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>ThermoCool SmartTouch 1</arm_group_label>
    <description>In this cohort are included patients who will undergo atrial fibrillation ablation using the ThermoCool SmartTouch Catheter and Ablation Index range: 380 for the posterior wall and 500 for the anterior wall</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ThermoCool SmartTouch 2</arm_group_label>
    <description>In this cohort are included patients who will undergo atrial fibrillation ablation using the ThermoCool SmartTouch Catheter and Ablation Index range: 330 for the posterior wall and 450 for the anterior wall</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ThermoCool SmartTouch SF 1</arm_group_label>
    <description>In this cohort are included patients who will undergo atrial fibrillation ablation using the ThermoCool SmartTouch SF Catheter and Ablation Index range: 330 for the posterior wall and 450 for the anterior wall</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ThermoCool SmartTouch SF 2</arm_group_label>
    <description>In this cohort are included patients who will undergo atrial fibrillation ablation using the ThermoCool SmartTouch SF Catheter and Ablation Index range: 380 for the posterior wall and 500 for the anterior wall</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PVI using ThermoCool® SmartTouch® Catheter</intervention_name>
    <description>PVI using RFA, using ThermoCool® SmartTouch® Catheter (Biosense Webster Inc., CA, US), guided by Ablation Index</description>
    <arm_group_label>ThermoCool SmartTouch 1</arm_group_label>
    <arm_group_label>ThermoCool SmartTouch 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PVI using ThermoCool® SmartTouch SF® Catheter</intervention_name>
    <description>PVI using RFA, using ThermoCool® SmartTouch SF® Catheter (Biosense Webster Inc., CA, US), guided by Ablation Index</description>
    <arm_group_label>ThermoCool SmartTouch SF 1</arm_group_label>
    <arm_group_label>ThermoCool SmartTouch SF 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with paroxysmal and persistent atrial fibrillation (AF) will undergo catheter&#xD;
        ablation using commercially approved devices (mapping system and catheters).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is indicated for catheter ablation for paroxysmal AF;&#xD;
&#xD;
          -  Subject is &gt; 18 years old;&#xD;
&#xD;
          -  Subject is &lt; 80 years old ;&#xD;
&#xD;
          -  Subject is on adequate anticoagulation therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had already undergo an AF ablation procedure;&#xD;
&#xD;
          -  Patients with left ventricular ejection fraction &lt; 35%&#xD;
&#xD;
          -  Women of childbearing potential who are or might be pregnant&#xD;
&#xD;
          -  Hematological contraindications to ionizing radiation exposure&#xD;
&#xD;
          -  Presence of complex congenital heart disease, and cardiac surgery within 1 month from&#xD;
             enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinica Mediterranea</name>
      <address>
        <city>Naples</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>El Haddad M, Taghji P, Phlips T, Wolf M, Demolder A, Choudhury R, Knecht S, Vandekerckhove Y, Tavernier R, Nakagawa H, Duytschaever M. Determinants of Acute and Late Pulmonary Vein Reconnection in Contact Force-Guided Pulmonary Vein Isolation: Identifying the Weakest Link in the Ablation Chain. Circ Arrhythm Electrophysiol. 2017 Apr;10(4):e004867. doi: 10.1161/CIRCEP.116.004867.</citation>
    <PMID>28381417</PMID>
  </reference>
  <reference>
    <citation>Das M, Loveday JJ, Wynn GJ, Gomes S, Saeed Y, Bonnett LJ, Waktare JEP, Todd DM, Hall MCS, Snowdon RL, Modi S, Gupta D. Ablation index, a novel marker of ablation lesion quality: prediction of pulmonary vein reconnection at repeat electrophysiology study and regional differences in target values. Europace. 2017 May 1;19(5):775-783. doi: 10.1093/europace/euw105.</citation>
    <PMID>27247002</PMID>
  </reference>
  <results_reference>
    <citation>Das M, Wynn GJ, Morgan M, Lodge B, Waktare JE, Todd DM, Hall MC, Snowdon RL, Modi S, Gupta D. Recurrence of atrial tachyarrhythmia during the second month of the blanking period is associated with more extensive pulmonary vein reconnection at repeat electrophysiology study. Circ Arrhythm Electrophysiol. 2015 Aug;8(4):846-52. doi: 10.1161/CIRCEP.115.003095. Epub 2015 Jun 24.</citation>
    <PMID>26108982</PMID>
  </results_reference>
  <results_reference>
    <citation>Stabile G, Di Donna P, Schillaci V, Di Monaco A, Iuliano A, Caponi D, Urraro F, Solimene F, Grimaldi M, Scaglione M. Safety and efficacy of pulmonary vein isolation using a surround flow catheter with contact force measurement capabilities: A multicenter registry. J Cardiovasc Electrophysiol. 2017 Jul;28(7):762-767. doi: 10.1111/jce.13227. Epub 2017 Jun 21.</citation>
    <PMID>28422368</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>August 2, 2018</last_update_submitted>
  <last_update_submitted_qc>August 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atrial fibrillation;</keyword>
  <keyword>catheter ablation;</keyword>
  <keyword>pulmonary vein isolation</keyword>
  <keyword>ablation index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- 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/NCT03277976
org study id: AIR Study
nct id: NCT03277976
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, multi-center, research study designed to evaluate the acute
      achievement of pulmonary vein (PV) isolation with ThermoCool SmartTouch (ST) and ThermoCool
      SmartTouch SF (STSF) catheter using the Ablation Index Module.
This is a prospective, multi-center, research study designed to evaluate the acute
      achievement of pulmonary vein (PV) isolation with ThermoCool SmartTouch (ST) and ThermoCool
      SmartTouch SF (STSF) catheter using the Ablation Index Module.

      Subjects with paroxysmal and persistent atrial fibrillation (AF) will undergo catheter
      ablation using commercially approved devices (mapping system and catheters).

      Patients will be followed up for 12 months to measure the recurrence of AF. This study is
      expected to start in September 2017 and to continue for approximately 26 months. It is
      anticipated that this study will require approximately 12 months for subject enrollment.
      Patients will be followed up for at least 12 months. Data analysis is expected to require
      approximately 2 months. At least 320 consecutive patients will be enrolled in the study
      centers. Patients will be divided in 4 groups and enrollment will stop when at least 80
      patients will be enrolled in each group. The investigators evaluate two ablation catheters
      (ST and STSF) and two different ablation index settings (380 posterior - 500 anterior and 330
      posterior - 450 anterior). Given that the rate of PV isolation with a standard wide antral
      circumferential ablation technique (WACA) is about 70%, the investigators want to test if one
      of two catheters or one of ablation index settings can increase the PV isolation rate of at
      least 10% (from 70% to 80%, 95% CI 75-85%).

      Primary endpoint The primary objective of this study is to evaluate which ablation strategy
      increase the rate of WACA PV isolation, validated by mean of LASSO catheter, after first
      encirclement, from 70% to 80%.

      Secondary endpoints Incidence of early PV reconnection 30 minutes after acute PV isolation.
      Difference in procedural and fluoroscopy time between the two groups. Incidence of AF
      recurrence during the blanking period (3-months after ablation).

      Safety of the ablation procedure. At least 320 patients undergoing catheter ablation for
      paroxysmal or persistent AF will be enrolled.

      Inclusion Criteria The following criteria must be met for subjects to be eligible for
      inclusion into the study Subject is indicated for catheter ablation for paroxysmal AF Subject
      is > 18 years old Subject is < 80 years old Subject is on adequate anticoagulation therapy

      Exclusion Criteria The following criteria are exclusions for study participation Patients who
      had already undergo an AF ablation procedure Patients with left ventricular ejection fraction
      < 35% Women of childbearing potential who are or might be pregnant Hematological
      contraindications to ionizing radiation exposure Presence of complex congenital heart
      disease, and cardiac surgery within 1 month from enrollment

      Patients will be screened in ambulatory and scheduled for AF ablation according to current
      guide lines. Ablation will be usually performed under effective oral anticoagulation.
      Anticoagulation could be withdrawn before admission, so as antiarrhythmic drugs will be
      removed before scheduled procedure. Patients in AF or with a CHA2DS2-VASc score ≥ 1 will
      undergo transesophageal echocardiography within 48 hours prior to the ablation. For all other
      patients transesophageal echocardiography is optional. Cardiac MRI or Cardiac CT scan could
      be executed as a reference for volume estimations obtained with the mapping system.

      Ablation will be carried out under mild or conscious sedation, at least 2 femoral vein access
      will be obtained and in some patients 1 subclavian vein. One diagnostic catheter will be
      positioned in the coronary sinus. One or two transseptal accesses to the left atrium will be
      achieved using a standard approach. Then, the LASSO catheter and the ablation catheter (ST
      and STSF) will be placed in the left atrium. Heparin will be administered before the
      transseptal punctures to maintain an activated clotting time ≥ 300 seconds for the duration
      of the procedure. Left atrium mapping will be performed in sinus rhythm. Patients with atrial
      fibrillation at the beginning of the index procedure will undergo electrical cardioversion.
      After left atrium reconstruction the effective PV-left atrium electrical connection will be
      checked with LASSO. In all groups a wide antrum circumferential ablation aimed at PV
      isolation will be performed using contact force threshold range between 5-40 g (14), and the
      Ablation Index Module, with the following preset: respiration adjustment; stability range 3
      mm, stability time 3 sec, force over time 25% of time, 3 g and ablation index thresholds: 500
      for anterior wall and 380 for posterior wall or 450 for anterior wall and 330 for posterior
      wall; contiguity lesion 5-6 mm (15-16). The default power setting will be 30 W, with ranges
      of 20-40 W. At the end of the ablation effective PV isolation (entry and exit block), will be
      checked with LASSO catheter. After PV isolation will be achieved, the reconnection of the
      same vein will be evaluated after a 30 minute period from the initial isolation or after
      adenosine infusion or isoproterenol. If the vein reconnects to the atrium, the ablation will
      be directed to the gaps identified by the LASSO catheter. All patients will undergo a
      post-procedural ECG and, optional, an echocardiogram to exclude pericardial effusion or other
      acute complications. After ablation, patients will undertake regular follow-up assessments
      (scheduled at 3 months) including a detailed history, physical examination, 12-lead standard
      electrocardiography, and 24-h Holter monitoring. Patients who will not report any symptoms
      related to the previous arrhythmia during a supplementary detailed follow up (6-12 months
      subsequent to catheter ablation) will be considered free of arrhythmia recurrence
observational model: Cohort
time perspective: Prospective
measure: The primary objective of this study is to evaluate which ablation strategy increase the rate of WACA PV isolation, validated by mean of LASSO catheter, after first encirclement, from 70% to 80%.
time frame: From the end of the WACA PV isolation up to 5 min after
measure: Incidence of early PV reconnection 30 minutes after acute PV isolation.
time frame: Up to 30 min after the effective pulmonary vein isolation
measure: Difference in procedural and fluoroscopy time between the two groups
time frame: From the beginning of the index procedure to the end of index procedure
measure: Incidence of AF recurrence during the blanking period
time frame: Up to 3 months after the ablation procedure
measure: Incidence of treatment-emergent adverse events.
time frame: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, from the index procedure to one-year follow-up
arm group label: ThermoCool SmartTouch 1
description: In this cohort are included patients who will undergo atrial fibrillation ablation using the ThermoCool SmartTouch Catheter and Ablation Index range: 380 for the posterior wall and 500 for the anterior wall
arm group label: ThermoCool SmartTouch 2
description: In this cohort are included patients who will undergo atrial fibrillation ablation using the ThermoCool SmartTouch Catheter and Ablation Index range: 330 for the posterior wall and 450 for the anterior wall
arm group label: ThermoCool SmartTouch SF 1
description: In this cohort are included patients who will undergo atrial fibrillation ablation using the ThermoCool SmartTouch SF Catheter and Ablation Index range: 330 for the posterior wall and 450 for the anterior wall
arm group label: ThermoCool SmartTouch SF 2
description: In this cohort are included patients who will undergo atrial fibrillation ablation using the ThermoCool SmartTouch SF Catheter and Ablation Index range: 380 for the posterior wall and 500 for the anterior wall
intervention type: Device
intervention name: PVI using ThermoCool® SmartTouch® Catheter
description: PVI using RFA, using ThermoCool® SmartTouch® Catheter (Biosense Webster Inc., CA, US), guided by Ablation Index
arm group label: ThermoCool SmartTouch 1
arm group label: ThermoCool SmartTouch 2
intervention type: Device
intervention name: PVI using ThermoCool® SmartTouch SF® Catheter
description: PVI using RFA, using ThermoCool® SmartTouch SF® Catheter (Biosense Webster Inc., CA, US), guided by Ablation Index
arm group label: ThermoCool SmartTouch SF 1
arm group label: ThermoCool SmartTouch SF 2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
citation: El Haddad M, Taghji P, Phlips T, Wolf M, Demolder A, Choudhury R, Knecht S, Vandekerckhove Y, Tavernier R, Nakagawa H, Duytschaever M. Determinants of Acute and Late Pulmonary Vein Reconnection in Contact Force-Guided Pulmonary Vein Isolation: Identifying the Weakest Link in the Ablation Chain. Circ Arrhythm Electrophysiol. 2017 Apr;10(4):e004867. doi: 10.1161/CIRCEP.116.004867.
PMID: 28381417
citation: Das M, Loveday JJ, Wynn GJ, Gomes S, Saeed Y, Bonnett LJ, Waktare JEP, Todd DM, Hall MCS, Snowdon RL, Modi S, Gupta D. Ablation index, a novel marker of ablation lesion quality: prediction of pulmonary vein reconnection at repeat electrophysiology study and regional differences in target values. Europace. 2017 May 1;19(5):775-783. doi: 10.1093/europace/euw105.
PMID: 27247002
citation: Das M, Wynn GJ, Morgan M, Lodge B, Waktare JE, Todd DM, Hall MC, Snowdon RL, Modi S, Gupta D. Recurrence of atrial tachyarrhythmia during the second month of the blanking period is associated with more extensive pulmonary vein reconnection at repeat electrophysiology study. Circ Arrhythm Electrophysiol. 2015 Aug;8(4):846-52. doi: 10.1161/CIRCEP.115.003095. Epub 2015 Jun 24.
PMID: 26108982
citation: Stabile G, Di Donna P, Schillaci V, Di Monaco A, Iuliano A, Caponi D, Urraro F, Solimene F, Grimaldi M, Scaglione M. Safety and efficacy of pulmonary vein isolation using a surround flow catheter with contact force measurement capabilities: A multicenter registry. J Cardiovasc Electrophysiol. 2017 Jul;28(7):762-767. doi: 10.1111/jce.13227. Epub 2017 Jun 21.
PMID: 28422368
responsible party type: Sponsor
mesh term: Atrial Fibrillation