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

NARecruitingINTERVENTIONAL
Enrollment

407

Participants

Timeline

Start Date

June 3, 2025

Primary Completion Date

April 30, 2027

Study Completion Date

January 31, 2028

Conditions
Persistent Atrial Fibrillation
Interventions
DEVICE

FARAPULSE™ 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)."

Trial Locations (13)

21287

RECRUITING

Johns Hopkins Hospital, Baltimore

29406

RECRUITING

Trident Medical Center, Charleston

30322

RECRUITING

Emory University Hospital, Atlanta

31404

RECRUITING

Memorial Health University Medical Center, Savannah

33133

RECRUITING

HCA Florida Mercy Hospital, Miami

36607

RECRUITING

Mobile Infirmary Medical Center, Mobile

43210

RECRUITING

Ohio State University Medical Center, Columbus

72401

RECRUITING

Arrhythmia Research Group-Research Facility, Jonesboro

75701

RECRUITING

Christus Trinity Mother Frances Health System, Tyler

02114

RECRUITING

Massachusetts General Hospital, Boston

08053

RECRUITING

Virtua Health Inc., Marlton

Unknown

RECRUITING

National Taiwan University Hospital, Taipei

RECRUITING

Taipei Veterans General Hospital, Taipei

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY