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Ground-Breaking Electroporation-based Intervention for PAROXysmal Atrial Fibrillation Treatment (BEAT PAROX-AF) (BEAT PAROX-AF)

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PVI using PEF
PVI using CFRF
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Paroxysmal Atrial Fibrillation, Cardiac Arrhythmia, Pulmonary vein Isolation, Catheter Ablation, RF Ablation, Pulsed Field Energy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with drug-resistant symptomatic PAF meeting all the following criteria:

    1. Paroxysmal: AF that terminates spontaneously or with intervention within 7 days of onset.
    2. Frequency:

    i. Physician documentation of recurrent PAF (two or more episodes) within 6 months, AND ii. At least one (1) documented episode by a recording such as ECG, Event Monitor, Holter monitor or telemetry strip within 12 months of enrolment.

    c. Drug failed: Failed AAD treatment, meaning therapeutic failure of at least one (1) AAD (Class I to IV) for efficacy and / or intolerance.

  2. Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
  3. Patient who are willing and capable of:

    1. Providing informed consent to undergo study procedures AND
    2. Participating in all examinations and follow-up visits and tests associated with this clinical study.
    3. Patient having a smart phone compatible with the Event Monitor device.
  4. Effective contraception for women of childbearing potential.
  5. Effective oral anticoagulation >3 weeks prior to planned ablation procedure
  6. Patient affiliated to or beneficiary of national health security scheme for French participants.

Exclusion Criteria:

  • 1. AF that is any of the following:

    1. Persistent (both early and longstanding) by diagnosis or continuous duration > 7 days
    2. Secondary to electrolyte imbalance, thyroid disease, alcohol or other reversible / non-cardiac causes 2. Any of the following atrial conditions:
    1. Left atrial anteroposterior diameter ≥ 5.5 cm (by MRI, CT or TTE)
    2. Any prior atrial endocardial or epicardial ablation procedure, other than right sided cavotricuspid isthmus ablation or for right sided SVT
    3. Any prior atrial surgery
    4. Intra-atrial septal patch or interatrial shunt
    5. Atrial myxoma
    6. Current LA thrombus
    7. LA appendage closure, device or occlusion, past or anticipated
    8. Any PV abnormality, stenosis or stenting (common and middle PVs are admissible) 3. At any time, one (1) or more of the following cardiovascular procedures, implants or conditions:

    a. Sustained ventricular tachycardia or any ventricular fibrillation b. Hemodynamically significant valvular disease: i. Valvular disease that is symptomatic ii. Valvular disease causing or exacerbating congestive heart failure iii. Aortic stenosis: if already characterized, valve area < 1.5cm or gradient > 20 mm Hg iv. Mitral stenosis: if already characterized, valve area < 1.5cm or gradient > 5 mm Hg v. Aortic or mitral regurgitation associated with abnormal LV function or hemodynamic measurements c. Hypertrophic cardiomyopathy d. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty e. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices f. Any inferior vena cava (IVC) filter, known inability to obtain vascular access or other contraindication to femoral access g. History of rheumatic fever h. History of congenital heart disease with any residual anatomic or conduction abnormality 4. Any of the following procedures, implants or conditions:

    a. At baseline: i. New York Heart Association (NYHA) Class III/IV ii. Left ventricular ejection fraction (LVEF) < 40% iii. Symptomatic hypotension iv. Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two BP measurements at baseline assessment) v. Symptomatic resting bradycardia vi. Implantable loop recorder or insertable cardiac monitor, b. Within the 3 months preceding the Consent Date: i. Myocardial infarction ii. Unstable angina iii. Percutaneous coronary intervention iv. Heart failure hospitalization v. Pericarditis or symptomatic pericardial effusion vi. Gastrointestinal bleeding c. Within the 6 months preceding the Consent Date: i. Heart surgery ii. Stroke, TIA or intracranial bleeding iii. Any thromboembolic event iv. Carotid stenting or endarterectomy 5. Diagnosed disorder of blood clotting or bleeding diathesis 6. Contraindication to, or unwillingness to use, systemic anticoagulation 7. Contraindication to both CT and MRI 8. Sensitivity to contrast media not controllable by premedication 9. Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period 10. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation, including but not limited to:

    1. Body Mass Index (BMI) > 40.0
    2. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
    3. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
    4. Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
    5. Active malignancy or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)
    6. Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
    7. Active systemic infection
    8. COVID-19 disease
    9. Current confirmed, active COVID-19 disease ii. Current positive test for SARS-CoV-2 iii. Confirmed COVID-19 disease not clinically resolved at least 3 months prior to the Consent Date.

    i. Other uncontrolled medical conditions that may modify device effect or increase risk, including uncontrolled diabetes mellitus (HgbA1c > 8.0% if test result already obtained), untreated obstructive sleep apnea or active alcohol abuse j. Predicted life expectancy less than one (1) year 11. Clinically significant psychological condition that in the Investigator's opinion would prohibit the subject's ability to meet the protocol requirements/ Patient under legal protection 12. Current or anticipated enrollment in any other clinical study. 13. Employees / family members of:

    1. FARAPULSE or any of its affiliates or contractors
    2. The Investigator, sub-Investigators, or their medical office or practice, or healthcare organizations at which study procedures may be performed.

Sites / Locations

  • Medical University of Graz
  • AZ Sint-Jan Brugge-Oostende
  • Homolka Hospital
  • Institute for Clinical and Experimental Medicine
  • CHU BordeauxRecruiting
  • CHU Toulouse
  • Clinique Pasteur, Toulouse
  • Cardiovascular Center Bad Neustadt
  • Deutsches Herzzentrum München

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEF Arm

Pulmonary vein isolation using Contact Force RF

Arm Description

PEF is a non-thermal ablation modality using extremely short high voltage pulses to induce cell death, with tissue selectivity, cardiomyocytes being much more sensitive to this energy than Phrenic nerve or Esophageal cells. Energy (2000 V) will be delivered 8 times per vein with 2 different catheter configurations and rotations

The PVI strategy using RF is very standard. The CARTO© platform will be used, with a contact force catheter (SmartTouch), aiming at an ablation index value of 300 to 400 on the posterior wall, and at least 500 on the anterior wall. Power will be limited to 35/45 W, with a distance between consecutive deliveries of 6 mm or less (CLOSE protocol).

Outcomes

Primary Outcome Measures

proportion of subjects experiencing 1-year single-procedure clinical success
The Primary Efficacy Endpoint is the proportion of subjects experiencing 1-year single-procedure clinical success, defined as (2017 HRS consensus statement): Successful index AF ablation Absence of atrial arrhythmia recurrence on any type of recording (≥ 30 sec by TTM (event monitor), Holters, 12-lead ECGs, rhythm strip or other diagnostic ECG documentation), Absence of use of class I or III AAD (except for non-atrial arrhythmia) Absence of redo ablation (except for typical flutter), in the 12 months following the index ablation procedure (including a blanking period of 60 days following the index ablation procedure).

Secondary Outcome Measures

proportion of subjects with 1-year multiple-procedures success
proportion of subjects with 1-year multiple-procedures success defined as the following up to 12 months following the index ablation procedure: Absence of atrial arrhythmia recurrence on any type of recording ((≥ 30 sec by TTM (event monitor), Holters, 12-lead ECGs, rhythm strip or other diagnostic ECG documentation), Absence of use of class I or III AAD (except for non-atrial arrhythmia)
health-related quality of life:
Health-related quality of life will be evaluated using the SF-12 questionnaire. The SF-12 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of two meta-scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). High score indicates better functioning
AF-specific quality of life
Improvement in AF-specific quality of life will be assessed using QualiTy-of-life (AFEQT) questionnaire. Scores range from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered)
Death
Proportion of participants with death
Stroke
Proportion of participants with
Embolic events from arrhythmia,
Proportion of participants with embolic events from arrhythmia
Myocardial infarction
Proportion of participants with Myocardial infarction
Persistent diaphragmatic paralysis
Proportion of participants with Persistent diaphragmatic paralysis
Transient ischemic attack (TIA)
Proportion of participants with Transient ischemic attack (TIA)
Peripheral or organ thromboembolism
Proportion of participants with Peripheral or organ thromboembolism
Cardiac Tamponade / Perforation
Proportion of participants with Cardiac Tamponade / Perforation
Pericarditis
Proportion of participants with Pericarditis
Hospitalisation
Proportion of participants with Hospitalisation (initial or prolonged), excluding hospitalisation solely due to arrhythmia recurrence
Heart block
Proportion of participants with Heart block
Vascular access complications
Proportion of participants with Vascular access complications
Pulmonary vein stenosis (PVS)
Proportion of participants with Pulmonary vein stenosis (PVS)
Atrio-oesophageal fistula
Proportion of participants with Atrio-oesophageal fistula
Total ablation procedure duration
Index Ablation Procedure parameters: Total ablation procedure duration (in minutes), skin to skin
Left atrial (LA) dwell time during ablation procedure
Index Ablation Procedure parameters: Left atrial (LA) dwell time, defined as the time (in minutes) transpiring from catheter entry to exit from the LA
Total fluoroscopy time during ablation procedure
Index Ablation Procedure parameters: Total fluoroscopy time (in minutes), skin-to-skin
PV diameter
Change in mean PV diameter 2 months
Incidence of acute vagal response during PVI
Incidence of acute vagal response during PVI
mean heart rate
Change in mean heart rate
heart rate variability
Change in heart rate variability

Full Information

First Posted
December 1, 2021
Last Updated
January 26, 2022
Sponsor
University Hospital, Bordeaux
Collaborators
Funding: European Commission (H2020)
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1. Study Identification

Unique Protocol Identification Number
NCT05159492
Brief Title
Ground-Breaking Electroporation-based Intervention for PAROXysmal Atrial Fibrillation Treatment (BEAT PAROX-AF)
Acronym
BEAT PAROX-AF
Official Title
Ground-Breaking Electroporation-based Intervention for PAROXysmal Atrial Fibrillation Treatment (BEAT PAROX-AF)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 27, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Funding: European Commission (H2020)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
BEAT AF is a randomized controlled trial aiming to demonstrate that pulsed field energy is faster, more effective and safer (tissue selectivity) than RF for paroxysmal AF ablation
Detailed Description
Atrial fibrillation (AF), the most common arrhythmia, accounts for 1/3rd of Cardiovascular expenses, with over 10 millions affected in Europe. In addition to significant impact on quality of life, AF exposes patients to stroke, heart failure, dementia and death. AF is the most commonly ablated arrhythmia. The Pulmonary Vein Isolation (PVI) is the cornerstone of AF ablation, preventing recurrences, especially in patients with paroxysmal AF. Catheter ablation of AF uses either radiofrequency (RF) or cryothermal (cryo) energy. Common to these thermal energy sources is their reliance on time-dependent conductive heating/cooling and the fact that these modalities ablate all tissue types indiscriminately. The ablation procedure remains long, requires skills and expertise, and has a limited success rate, mostly because of non-durable lesions after PVI implying frequent redo procedures. And these energies are associated with rare but severe complications due to their thermal nature. The goal of BEAT AF is to disrupt AF ablation by achieving durable PVI with permanent, coalescent and transmural ablation lesions using Pulsed Electric Field (PEF) energy. PEF is non-thermal and creates nanoscale pores in cell membranes. Cardiac cells are highly sensitive to PEF unlike phrenic and oesophageal cells. BEAT AF aims to demonstrate that PEF ablation is faster, more effective and safer (tissue selectivity) than RF ablation to treat paroxysmal AF. For this purpose, a randomized clinical trial will be conducted to provide first comparative evidence of the superiority of PEF over RF on the rate of 1-year recurrence for paroxysmal AF. The BEAT AF consortium gathers 9 European renowned clinical centres (France, Czech Republic, Germany, Austria, Belgium) to contribute to decrease the huge burden of AF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Paroxysmal Atrial Fibrillation, Cardiac Arrhythmia, Pulmonary vein Isolation, Catheter Ablation, RF Ablation, Pulsed Field Energy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-label randomised controlled trial, in two parallel groups with a 1:1 allocation ratio
Masking
Participant
Allocation
Randomized
Enrollment
292 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEF Arm
Arm Type
Experimental
Arm Description
PEF is a non-thermal ablation modality using extremely short high voltage pulses to induce cell death, with tissue selectivity, cardiomyocytes being much more sensitive to this energy than Phrenic nerve or Esophageal cells. Energy (2000 V) will be delivered 8 times per vein with 2 different catheter configurations and rotations
Arm Title
Pulmonary vein isolation using Contact Force RF
Arm Type
Active Comparator
Arm Description
The PVI strategy using RF is very standard. The CARTO© platform will be used, with a contact force catheter (SmartTouch), aiming at an ablation index value of 300 to 400 on the posterior wall, and at least 500 on the anterior wall. Power will be limited to 35/45 W, with a distance between consecutive deliveries of 6 mm or less (CLOSE protocol).
Intervention Type
Device
Intervention Name(s)
PVI using PEF
Intervention Description
PVI using PEF
Intervention Type
Device
Intervention Name(s)
PVI using CFRF
Intervention Description
PVI using CFRF
Primary Outcome Measure Information:
Title
proportion of subjects experiencing 1-year single-procedure clinical success
Description
The Primary Efficacy Endpoint is the proportion of subjects experiencing 1-year single-procedure clinical success, defined as (2017 HRS consensus statement): Successful index AF ablation Absence of atrial arrhythmia recurrence on any type of recording (≥ 30 sec by TTM (event monitor), Holters, 12-lead ECGs, rhythm strip or other diagnostic ECG documentation), Absence of use of class I or III AAD (except for non-atrial arrhythmia) Absence of redo ablation (except for typical flutter), in the 12 months following the index ablation procedure (including a blanking period of 60 days following the index ablation procedure).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
proportion of subjects with 1-year multiple-procedures success
Description
proportion of subjects with 1-year multiple-procedures success defined as the following up to 12 months following the index ablation procedure: Absence of atrial arrhythmia recurrence on any type of recording ((≥ 30 sec by TTM (event monitor), Holters, 12-lead ECGs, rhythm strip or other diagnostic ECG documentation), Absence of use of class I or III AAD (except for non-atrial arrhythmia)
Time Frame
1 year
Title
health-related quality of life:
Description
Health-related quality of life will be evaluated using the SF-12 questionnaire. The SF-12 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of two meta-scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). High score indicates better functioning
Time Frame
6 months, 1 year
Title
AF-specific quality of life
Description
Improvement in AF-specific quality of life will be assessed using QualiTy-of-life (AFEQT) questionnaire. Scores range from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered)
Time Frame
6 months, 1 year
Title
Death
Description
Proportion of participants with death
Time Frame
7 days, 1 year
Title
Stroke
Description
Proportion of participants with
Time Frame
7 days, 1 year
Title
Embolic events from arrhythmia,
Description
Proportion of participants with embolic events from arrhythmia
Time Frame
1 year
Title
Myocardial infarction
Description
Proportion of participants with Myocardial infarction
Time Frame
7 days
Title
Persistent diaphragmatic paralysis
Description
Proportion of participants with Persistent diaphragmatic paralysis
Time Frame
7 days
Title
Transient ischemic attack (TIA)
Description
Proportion of participants with Transient ischemic attack (TIA)
Time Frame
7 days
Title
Peripheral or organ thromboembolism
Description
Proportion of participants with Peripheral or organ thromboembolism
Time Frame
7 days
Title
Cardiac Tamponade / Perforation
Description
Proportion of participants with Cardiac Tamponade / Perforation
Time Frame
7 days
Title
Pericarditis
Description
Proportion of participants with Pericarditis
Time Frame
7 days
Title
Hospitalisation
Description
Proportion of participants with Hospitalisation (initial or prolonged), excluding hospitalisation solely due to arrhythmia recurrence
Time Frame
7 days
Title
Heart block
Description
Proportion of participants with Heart block
Time Frame
7 days
Title
Vascular access complications
Description
Proportion of participants with Vascular access complications
Time Frame
7 days
Title
Pulmonary vein stenosis (PVS)
Description
Proportion of participants with Pulmonary vein stenosis (PVS)
Time Frame
1 year
Title
Atrio-oesophageal fistula
Description
Proportion of participants with Atrio-oesophageal fistula
Time Frame
1 year
Title
Total ablation procedure duration
Description
Index Ablation Procedure parameters: Total ablation procedure duration (in minutes), skin to skin
Time Frame
Baseline
Title
Left atrial (LA) dwell time during ablation procedure
Description
Index Ablation Procedure parameters: Left atrial (LA) dwell time, defined as the time (in minutes) transpiring from catheter entry to exit from the LA
Time Frame
Baseline
Title
Total fluoroscopy time during ablation procedure
Description
Index Ablation Procedure parameters: Total fluoroscopy time (in minutes), skin-to-skin
Time Frame
Baseline
Title
PV diameter
Description
Change in mean PV diameter 2 months
Time Frame
2 months
Title
Incidence of acute vagal response during PVI
Description
Incidence of acute vagal response during PVI
Time Frame
Baseline
Title
mean heart rate
Description
Change in mean heart rate
Time Frame
1 year
Title
heart rate variability
Description
Change in heart rate variability
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with drug-resistant symptomatic PAF meeting all the following criteria: Paroxysmal: AF that terminates spontaneously or with intervention within 7 days of onset. Frequency: i. Physician documentation of recurrent PAF (two or more episodes) within 6 months, AND ii. At least one (1) documented episode by a recording such as ECG, Event Monitor, Holter monitor or telemetry strip within 12 months of enrolment. c. Drug failed: Failed AAD treatment, meaning therapeutic failure of at least one (1) AAD (Class I to IV) for efficacy and / or intolerance. Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment. Patient who are willing and capable of: Providing informed consent to undergo study procedures AND Participating in all examinations and follow-up visits and tests associated with this clinical study. Patient having a smart phone compatible with the Event Monitor device. Effective contraception for women of childbearing potential. Effective oral anticoagulation >3 weeks prior to planned ablation procedure Patient affiliated to or beneficiary of national health security scheme for French participants. Exclusion Criteria: 1. AF that is any of the following: Persistent (both early and longstanding) by diagnosis or continuous duration > 7 days Secondary to electrolyte imbalance, thyroid disease, alcohol or other reversible / non-cardiac causes 2. Any of the following atrial conditions: Left atrial anteroposterior diameter ≥ 5.5 cm (by MRI, CT or TTE) Any prior atrial endocardial or epicardial ablation procedure, other than right sided cavotricuspid isthmus ablation or for right sided SVT Any prior atrial surgery Intra-atrial septal patch or interatrial shunt Atrial myxoma Current LA thrombus LA appendage closure, device or occlusion, past or anticipated Any PV abnormality, stenosis or stenting (common and middle PVs are admissible) 3. At any time, one (1) or more of the following cardiovascular procedures, implants or conditions: a. Sustained ventricular tachycardia or any ventricular fibrillation b. Hemodynamically significant valvular disease: i. Valvular disease that is symptomatic ii. Valvular disease causing or exacerbating congestive heart failure iii. Aortic stenosis: if already characterized, valve area < 1.5cm or gradient > 20 mm Hg iv. Mitral stenosis: if already characterized, valve area < 1.5cm or gradient > 5 mm Hg v. Aortic or mitral regurgitation associated with abnormal LV function or hemodynamic measurements c. Hypertrophic cardiomyopathy d. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty e. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices f. Any inferior vena cava (IVC) filter, known inability to obtain vascular access or other contraindication to femoral access g. History of rheumatic fever h. History of congenital heart disease with any residual anatomic or conduction abnormality 4. Any of the following procedures, implants or conditions: a. At baseline: i. New York Heart Association (NYHA) Class III/IV ii. Left ventricular ejection fraction (LVEF) < 40% iii. Symptomatic hypotension iv. Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two BP measurements at baseline assessment) v. Symptomatic resting bradycardia vi. Implantable loop recorder or insertable cardiac monitor, b. Within the 3 months preceding the Consent Date: i. Myocardial infarction ii. Unstable angina iii. Percutaneous coronary intervention iv. Heart failure hospitalization v. Pericarditis or symptomatic pericardial effusion vi. Gastrointestinal bleeding c. Within the 6 months preceding the Consent Date: i. Heart surgery ii. Stroke, TIA or intracranial bleeding iii. Any thromboembolic event iv. Carotid stenting or endarterectomy 5. Diagnosed disorder of blood clotting or bleeding diathesis 6. Contraindication to, or unwillingness to use, systemic anticoagulation 7. Contraindication to both CT and MRI 8. Sensitivity to contrast media not controllable by premedication 9. Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period 10. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation, including but not limited to: Body Mass Index (BMI) > 40.0 Solid organ or hematologic transplant, or currently being evaluated for an organ transplant Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant Active malignancy or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma) Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration Active systemic infection COVID-19 disease Current confirmed, active COVID-19 disease ii. Current positive test for SARS-CoV-2 iii. Confirmed COVID-19 disease not clinically resolved at least 3 months prior to the Consent Date. i. Other uncontrolled medical conditions that may modify device effect or increase risk, including uncontrolled diabetes mellitus (HgbA1c > 8.0% if test result already obtained), untreated obstructive sleep apnea or active alcohol abuse j. Predicted life expectancy less than one (1) year 11. Clinically significant psychological condition that in the Investigator's opinion would prohibit the subject's ability to meet the protocol requirements/ Patient under legal protection 12. Current or anticipated enrollment in any other clinical study. 13. Employees / family members of: FARAPULSE or any of its affiliates or contractors The Investigator, sub-Investigators, or their medical office or practice, or healthcare organizations at which study procedures may be performed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Jais, MD, PhD
Phone
+33 5 57 65 64 71
Email
pierre.jais@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Derval, MD
Email
nicolas.derval@chu-bordeaux.fr
Facility Information:
Facility Name
Medical University of Graz
City
Graz
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Scherr, MD
Email
daniel.scherr@medunigraz.at
Facility Name
AZ Sint-Jan Brugge-Oostende
City
Bruges
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastien Knecht, MD
Email
sebastien.knecht@azsintjan.be
Facility Name
Homolka Hospital
City
Prague
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petr Neuzil, MD
Email
pneuzil@seznam.cz
Facility Name
Institute for Clinical and Experimental Medicine
City
Prague
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josef Kautzner, MD
Email
josef.kautzner@ikem.cz
Facility Name
CHU Bordeaux
City
Pessac
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Derval, MD
Email
nicolas.derval@chu-bordeaux.fr
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Maury, PD, PhD
Email
maury.p@chu-toulouse.fr
Facility Name
Clinique Pasteur, Toulouse
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serge Boveda, MD
Email
sboveda@clinique-pasteur.com
Facility Name
Cardiovascular Center Bad Neustadt
City
Bad Neustadt an der Saale
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Deneke, MD
Email
thomas.deneke@campus-nes.de
Facility Name
Deutsches Herzzentrum München
City
Munich
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Deisenhofer, MD
Email
deisenhofer@dhm.mhn.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Ground-Breaking Electroporation-based Intervention for PAROXysmal Atrial Fibrillation Treatment (BEAT PAROX-AF)

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