Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation
NCT ID: NCT06364215
Last Updated: 2025-11-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
198 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-10-08
Study Completion Date
2025-11-16
Brief Summary
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The purpose of this study is to compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF).
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Detailed Description
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This is an investigator-initiated, prospective, randomized, multi-center, Investigational Device Exemption (IDE) study. Subjects undergoing first-time ablation for paroxysmal atrial fibrillation will be randomized to receive either pulmonary vein isolation (PVI) alone or PVI combined with posterior wall isolation (PWI) using pulsed field ablation (PFA) with the FARAWAVE PFA catheter.
Following the index procedure, all participants will enter a 3-month blanking period, during which they will be closely monitored. After this period, anti-arrhythmic drug (AAD) therapy will be discontinued for all patients. Throughout the entire study, patients will be monitored using an implantable loop recorder (ILR) to assess the primary outcome of efficacy.
The study includes a 12-month follow-up period, and the primary objective is to assess and compare the efficacy, defined as an improvement in freedom from all-atrial arrhythmias, and safety, defined as the occurrence of all procedure-related complications.
Following the index procedure, all participants will enter a 3-month blanking period, during which they will be closely monitored. After this period, anti-arrhythmic drug (AAD) therapy will be discontinued for all patients. Throughout the entire study, patients will be monitored using an implantable loop recorder (ILR) to assess the primary outcome of efficacy.
The study includes a 12-month follow-up period, and the primary objective is to assess and compare the efficacy, defined as an improvement in freedom from all-atrial arrhythmias, and safety, defined as the occurrence of all procedure-related complications.
Conditions
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Atrial Fibrillation Paroxysmal
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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Pulmonary Vein Isolation (PVI) only
Pulsed field ablation of the pulmonary veins only.
Group Type
ACTIVE_COMPARATOR
Farapulse PFA, Pulmonary Vein Isolation alone
Intervention Type
DEVICE
Ablation of the pulmonary veins for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation.
Pulmonary Vein Isolation and Posterior Wall Isolation ( PVI+PWI)
Pulsed field ablation of the pulmonary veins and the posterior wall of the left atrium.
Group Type
ACTIVE_COMPARATOR
Farapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation
Intervention Type
DEVICE
Ablation of the pulmonary veins and the left atrium posterior wall for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation.
Interventions
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Farapulse PFA, Pulmonary Vein Isolation alone
Ablation of the pulmonary veins for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation.
Intervention Type
DEVICE
Farapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation
Ablation of the pulmonary veins and the left atrium posterior wall for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Age 21-90 years.
4. Symptomatic PAF whether failed AAD or not.
5. At least one symptomatic episode of PAF lasting \<7 days, documented on electrocardiogram (ECG), Holter, ZioPatch, ILR, or smartwatch recording in the year prior to enrollment.
6. Patients undergoing first time ablation for AF.
7. Subject has any commercially available implantable loop recorder (ILR) or agrees to have one implanted prior or during the ablation procedure.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Age 21-90 years.
4. Symptomatic PAF whether failed AAD or not.
5. At least one symptomatic episode of PAF lasting \<7 days, documented on electrocardiogram (ECG), Holter, ZioPatch, ILR, or smartwatch recording in the year prior to enrollment.
6. Patients undergoing first time ablation for AF.
7. Subject has any commercially available implantable loop recorder (ILR) or agrees to have one implanted prior or during the ablation procedure.
Exclusion Criteria
1. Persistent atrial fibrillation (PeAF) (\> 7 days in duration).
2. Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or other reversible non-cardiac cause.
3. Previous surgical or catheter ablation of AF.
4. Previous valve surgery, ventriculotomy, atriotomy, or presence of a mitral mechanical prosthetic or bioprosthetic valve.
5. Left atrium anteroposterior (LA AP) diameter \>55 mm or indexed left atrium (LA) volume \>48 ml/m2.
6. Contraindications to oral or systemic anticoagulation.
7. Previous thromboembolic event (including ischemic strokes and TIA) within the last 3 months.
8. Previous myocardial infarction or percutaneous coronary intervention within the past 2 months.
9. Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days).
10. Pregnancy.
11. History of PV stenosis.
12. History of severe pulmonary hypertension.
13. History of diaphragmatic paresis or hemi-paresis.
14. History of heart transplantation.
15. History of blood clotting or bleeding abnormalities.
16. Life expectancy of less than 12 months.
17. Presence of intracardiac thrombus.
18. Complex congenital heart disease, including tetralogy of Fallot, ventricular septal defects, Ebstein's anomaly, systemic right ventricle, and transposition of the great arteries.
19. Intracardiac or vascular abnormalities that preclude adequate catheter introduction or manipulation within the LA.
20. Pacing dependent patients.
21. Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma).
22. Active systemic infection.
23. Participation in any other AF-related randomized clinical trial.
2. Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or other reversible non-cardiac cause.
3. Previous surgical or catheter ablation of AF.
4. Previous valve surgery, ventriculotomy, atriotomy, or presence of a mitral mechanical prosthetic or bioprosthetic valve.
5. Left atrium anteroposterior (LA AP) diameter \>55 mm or indexed left atrium (LA) volume \>48 ml/m2.
6. Contraindications to oral or systemic anticoagulation.
7. Previous thromboembolic event (including ischemic strokes and TIA) within the last 3 months.
8. Previous myocardial infarction or percutaneous coronary intervention within the past 2 months.
9. Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days).
10. Pregnancy.
11. History of PV stenosis.
12. History of severe pulmonary hypertension.
13. History of diaphragmatic paresis or hemi-paresis.
14. History of heart transplantation.
15. History of blood clotting or bleeding abnormalities.
16. Life expectancy of less than 12 months.
17. Presence of intracardiac thrombus.
18. Complex congenital heart disease, including tetralogy of Fallot, ventricular septal defects, Ebstein's anomaly, systemic right ventricle, and transposition of the great arteries.
19. Intracardiac or vascular abnormalities that preclude adequate catheter introduction or manipulation within the LA.
20. Pacing dependent patients.
21. Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma).
22. Active systemic infection.
23. Participation in any other AF-related randomized clinical trial.
Minimum Eligible Age
21 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Sponsor Role
collaborator
Databean
INDUSTRY
Sponsor Role
collaborator
Brigham and Women's Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Jorge E. Romero, MD
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Jorge E Romero, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
William H Sauer, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Grandview Medical Center
Birmingham, Alabama, United States
Site Status
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Site Status
St. Vincent's Health System, Inc. d/b/a Ascension St. Vincent's
Jacksonville, Florida, United States
Site Status
HCA Florida Mercy Hospital
Miami, Florida, United States
Site Status
St. Luke's Boise Medical Center
Boise, Idaho, United States
Site Status
Maine Medical Center
Portland, Maine, United States
Site Status
Brigham and Women's Hospital
Boston, Massachusetts, United States
Site Status
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Site Status
Corewell Health William Beaumont Hospital
Royal Oak, Michigan, United States
Site Status
The Valley Hospital
Paramus, New Jersey, United States
Site Status
North Shore University Hospital, Northwell Health
Manhasset, New York, United States
Site Status
Doylestown Hospital
Doylestown, Pennsylvania, United States
Site Status
Trident Medical Center
Charleston, South Carolina, United States
Site Status
Medical University of South Carolina
Charleston, South Carolina, United States
Site Status
Orion Medical
Houston, Texas, United States
Site Status
Methodist Hospital-San Antonio
San Antonio, Texas, United States
Site Status
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Site Status
University of Washington Medical Center
Seattle, Washington, United States
Site Status
Countries
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United States
References
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Venier S, Vaxelaire N, Jacon P, Carabelli A, Desbiolles A, Garban F, Defaye P. Severe acute kidney injury related to haemolysis after pulsed field ablation for atrial fibrillation. Europace. 2023 Dec 28;26(1):euad371. doi: 10.1093/europace/euad371.
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024P000883
Identifier Type: -
Identifier Source: org_study_id
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