Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation

NCT06364215 | Terminated DMC FDA Device

• 1 other identifier: 2024P000883
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 18

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).

Conditions

Atrial Fibrillation Paroxysmal

Keywords

pulsed field ablation; paroxysmal atrial fibrillation; left atrium posterior wall isolation; pulmonary vein isolation

Outcome Measures

Primary Outcomes (2)

• Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period.

  will be assessed by: * Occurrence of all atrial arrhythmias after the 3-month blanking period. * Any cardioversion for atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) after the 3-month blanking period. * Use of any type I or type III antiarrhythmic medication for the treatment of AF, AFL, or AT after the 3-month blanking period, or the use of amiodarone at any time. * Re-ablation of AF, AFL, or AT.

  12 months

• 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.

  All number of acute procedure-related complications will be reported and assessed including: atrio-esophageal fistula, cardiac perforation, pulmonary vein (PV) stenosis, acute kidney injury, phrenic nerve paralysis, thromboembolic events, stroke, or transient ischemic attacks (TIA), and other major adverse events within the 12 months following the ablation procedure: pericarditis cardiac tamponade pericardial effusion, coronary artery spasm, Vascular access complication/major bleeding, local hematoma, ecchymosis left atrium or vascular laceration

  12 Months

Secondary Outcomes (9)

• Freedom from atrial arrhythmias medication

  12 Months

• Procedural time

  12 Months

• Procedure-related Recurrencies

  12 Months

• Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT).

  12 Months

• Use of amiodarone

  12 months

Study Arms (2)

Pulmonary Vein Isolation (PVI) only

ACTIVE COMPARATOR

Pulsed field ablation of the pulmonary veins only.

Device: Farapulse PFA, Pulmonary Vein Isolation alone

Pulmonary Vein Isolation and Posterior Wall Isolation ( PVI+PWI)

ACTIVE COMPARATOR

Pulsed field ablation of the pulmonary veins and the posterior wall of the left atrium.

Device: Farapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation

Interventions

Farapulse PFA, Pulmonary Vein Isolation alone DEVICE

Ablation of the pulmonary veins for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation.

Pulmonary Vein Isolation (PVI) only

Farapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation DEVICE

Ablation of the pulmonary veins and the left atrium posterior wall for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation.

Pulmonary Vein Isolation and Posterior Wall Isolation ( PVI+PWI)

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Age 21-90 years.
• Symptomatic PAF whether failed AAD or not.
• 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.
• Patients undergoing first time ablation for AF.
• Subject has any commercially available implantable loop recorder (ILR) or agrees to have one implanted prior or during the ablation procedure.

You may not qualify if:

• Persistent atrial fibrillation (PeAF) (\> 7 days in duration).
• Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or other reversible non-cardiac cause.
• Previous surgical or catheter ablation of AF.
• Previous valve surgery, ventriculotomy, atriotomy, or presence of a mitral mechanical prosthetic or bioprosthetic valve.
• Left atrium anteroposterior (LA AP) diameter \>55 mm or indexed left atrium (LA) volume \>48 ml/m2.
• Contraindications to oral or systemic anticoagulation.
• Previous thromboembolic event (including ischemic strokes and TIA) within the last 3 months.
• Previous myocardial infarction or percutaneous coronary intervention within the past 2 months.
• Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days).
• Pregnancy.
• History of PV stenosis.
• History of severe pulmonary hypertension.
• History of diaphragmatic paresis or hemi-paresis.
• History of heart transplantation.
• History of blood clotting or bleeding abnormalities.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Boston Scientific Corporation: collaborator
• Databean: collaborator

Study Sites (18)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

St. Vincent's Health System, Inc. d/b/a Ascension St. Vincent's

Jacksonville, Florida, 32204, United States

Location

HCA Florida Mercy Hospital

Miami, Florida, 33133, United States

Location

St. Luke's Boise Medical Center

Boise, Idaho, 83712, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Corewell Health William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

The Valley Hospital

Paramus, New Jersey, 07652, United States

Location

North Shore University Hospital, Northwell Health

Manhasset, New York, 11030, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Trident Medical Center

Charleston, South Carolina, 29406, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Orion Medical

Houston, Texas, 77034, United States

Location

Methodist Hospital-San Antonio

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

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• Mohanty S, Casella M, Compagnucci P, Torlapati PG, Della Rocca DG, La Fazia VM, Gianni C, Chierchia GB, MacDonald B, Mayedo A, Khan UN, Allison J, Bassiouny M, Gallinghouse GJ, Burkhardt JD, Horton R, Al-Ahmad A, Di Biase L, de Asmundis C, Russo AD, Natale A. Acute Kidney Injury Resulting From Hemoglobinuria After Pulsed-Field Ablation in Atrial Fibrillation: Is it Preventable? JACC Clin Electrophysiol. 2024 Apr;10(4):709-715. doi: 10.1016/j.jacep.2023.12.008. Epub 2024 Feb 1.

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MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jorge E Romero, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• William H Sauer, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 15, 2024
• Study Start: October 8, 2024
• Primary Completion: November 16, 2025
• Study Completion: November 16, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)