RecruitingNot ApplicableNCT06735534

Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System

The ReMATCH Study is a Prospective, Single Arm, Open Label, Multi-center, Study Utilizing the FARAPULSE PFA System, Including the FARAWAVE and FARAPOINT PFA Catheters

Sponsor

Boston Scientific Corporation

Enrollment

376 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

Persistent Atrial Fibrillation

Summary

The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a repeat heart procedure called catheter ablation using a newer technology called pulsed field ablation (PFA) to treat persistent atrial fibrillation (an irregular heartbeat that doesn't stop on its own) in patients whose first ablation didn't fully work. **You may be eligible if...** - You are 18 years of age or older - You previously had one catheter ablation procedure for atrial fibrillation (AF) within the last 5 years - Your AF has come back after your first procedure - Your AF is now persistent (not stopping on its own) and was confirmed at least 60 days after your first procedure **You may NOT be eligible if...** - You have had more than one prior ablation - You have structural heart problems that make the procedure unsafe - You have a history of blood clots in the left atrium Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFARAPULSE™ Pulsed Field Ablation System

The FARAPULSE™ Pulsed Field Ablation System is indicated for the treatment of symptomatic atrial fibrillation. The FARAWAVE Catheter is indicated for the isolation of pulmonary veins and posterior wall in the treatment of drug-refractory, recurrent, symptomatic paroxysmal and persistent atrial fibrillation. The FARAWAVE Catheter is also indicated for the for the isolation of pulmonary veins and posterior wall in the treatment of persistent atrial fibrillation as an alternative to anti-arrhythmic drug (AAD) therapy as an initial rhythm control strategy. The FARAPOINT™ PFA Catheter is indicated for use as an adjunctive device for 1) the creation of an ablation line between the inferior vena cava and the tricuspid valve and/or 2) Mitral Isthmus, when the FARAWAVE Catheter is used in the endocardial treatment of persistent atrial fibrillation (episode duration no greater than 12 months).

Locations(34)

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Arrhythmia Research Group-Research Facility

Jonesboro, Arkansas, United States

University of Southern California Hospital

Los Angeles, California, United States

Stanford University Medical Center

Stanford, California, United States

South Denver Cardiology Associates, PC

Littleton, Colorado, United States

HCA Florida Mercy Hospital

Miami, Florida, United States

Naples Comprehensive Health

Naples, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

St. Luke's Boise Medical Center

Boise, Idaho, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Southcoast Physicians Group

Fall River, Massachusetts, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Virtua Health Inc.

Marlton, New Jersey, United States

Lovelace Medical Center

Albuquerque, New Mexico, United States

Northwell Health

Manhasset, New York, United States

Weill Cornell Medical University

New York, New York, United States

Bethesda North Hospital

Cincinnati, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Oklahoma Heart Institute

Tulsa, Oklahoma, United States

Trident Medical Center

Charleston, South Carolina, United States

Texas Cardiac Arrhythmia Research

Austin, Texas, United States

Christus Trinity Mother Frances Health System

Tyler, Texas, United States

St. Mark's Hospital

Salt Lake City, Utah, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

St. Andrew's War Memorial Hospital

Brisbane, Queensland, Australia

Victorian Heart Hospital

Clayton, Victoria, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

The Alfred Hospital

Melbourne, Australia

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06735534

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