Clinical trial NCT06364215: Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation
Official title: Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation Paroxysmal
Keywords: pulsed field ablation
paroxysmal atrial fibrillation
left atrium posterior wall isolation
pulmonary vein isolation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
name: Databean
First posted: 2024-04-15
Enrollment: 450
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period.
timeFrame: 12 months
measure: The primary safety endpoint is a composite of acute procedure-related complications and any other major adverse events within the 12 months following the ablation procedure.
timeFrame: 12 Months
Secondary outcomes:
measure: Freedom from atrial arrhythmias medication
timeFrame: 12 Months
measure: Procedural time
timeFrame: 12 Months
measure: Procedure-related Recurrencies
timeFrame: 12 Months
measure: Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT).
timeFrame: 12 Months
measure: Use of amiodarone
timeFrame: 12 months
measure: Complications.
timeFrame: 12 Months.
measure: fluoroscopy time.
timeFrame: during 1-2 hours procedure.
measure: Pulsed field ablation (PFA) applications during procedure.
timeFrame: During 1-2 hours procedure.
measure: first-pass pulmonary vein isolation (PVI).
timeFrame: During 1-2 hours procedure.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Jacksonville
country: United States
facility: St. Vincent's Health System, Inc. d/b/a Ascension St. Vincent's
state: Florida
city: Miami
country: United States
facility: HCA Florida Mercy Hospital
state: Florida
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Manhasset
country: United States
facility: North Shore University Hospital, Northwell Health
state: New York
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Trident Medical Center
state: South Carolina
Study officials:
affiliation: Mass General Brigham
name: Jorge E Romero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mass General Brigham
name: William H Sauer, MD
role: PRINCIPAL_INVESTIGATOR
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