A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation

NAActive, not recruitingINTERVENTIONAL
Enrollment

669

Participants

Timeline

Start Date

February 28, 2023

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2025

Conditions
Persistent Atrial Fibrillation
Interventions
DEVICE

Phase 1: FARAPULSE Ablation System

PHASE 1: Pulsed Field Ablation to isolate the Pulmonary Veins and Posterior Wall using the FARAPULSE Ablation System.

DEVICE

Phase 2: FARAPULSE Ablation System

PHASE 2: Pulsed Field Ablation to isolate the Pulmonary Veins, Posterior Wall and Cavo-Tricuspid Isthmus using the FARAPULSE Ablation System.

Trial Locations (44)

1090

UZ Brussel (AZ VUB)-Hospital, Brussels

10016

NYU Langone Health Heart Rhythm Center, New York

10021

Weill Cornell Medical University-Hospital, New York

10029

Mount Sinai Medical Center-Hospital, New York

10075

Lenox Hill Hospital, New York

11576

St. Francis Hospital-Hospital, Roslyn

17101

UPMC Heart and Vascular Institute Harrisburg, Harrisburg

18901

Doylestown Hospital-Hospital, Doylestown

19104

Hospital of the University of Pennsylvania-Hospital, Philadelphia

21287

Johns Hopkins Hospital - East Baltimore Campus, Baltimore

23219

Virginia Commonwealth University Health System-Hospital, Richmond

23507

Sentara Norfolk General Hospital-Hospital, Norfolk

29406

Trident Medical Center-Hospital, Charleston

30322

Emory University Hospital-Hospital, Atlanta

31008

Clinica Universidad de Navarra-Hospital, Pamplona

35243

Grandview Medical Center-Hospital, Birmingham

37205

St. Thomas Research Institute, LLC-Hospital, Nashville

37232

Vanderbilt University Medical Center-Hospital, Nashville

40503

Baptist Health Lexington, Lexington

43214

OhioHealth Research and Innovation Institute - Riverside Methodist Hospital-Hospital, Columbus

44195

Cleveland Clinic Foundation-Hospital, Cleveland

45242

Bethesda North Hospital-Hospital, Cincinnati

46260

St. Vincent's Hospital-Hospital, Indianapolis

50266

Mercy Hospital Medical Center-Hospital, West Des Moines

60208

Northwestern University-Hospital, Evanston

62769

St. John's Hospital-Hospital, Springfield

64111

St. Luke's Hospital of Kansas City-Hospital, Kansas City

66160

University of Kansas Hospital-Hospital, Kansas City

72401

Arrhythmia Research Group-Research Facility, Jonesboro

75701

Christus Trinity Mother Frances Health System-Hospital, Tyler

77034

Orion Medical - Gulf Commerce Drive, Houston

78705

Texas Cardiac Arrhythmia Research-Hospital, Austin

83712

St. Lukes Idaho Cardiology Associates-Hospital, Boise

85006

Banner University Medical Center Phoenix-Hospital, Phoenix

90048

Cedars - Sinai Medical Center-Hospital, Los Angeles

92037

Scripps Memorial Hospital-Hospital, La Jolla

94143-0112

University of California, San Francisco-Hospital, San Francisco

02114

Massachusetts General Hospital-Hospital, Boston

02115

Brigham and Women's Hospital-Hospital, Boston

01805

Lahey Clinic Hospital-Hospital, Burlington

03102

Catholic Medical Center-Hospital, Manchester

07450

Valley Hospital-Hospital, Ridgewood

H3G 1A4

McGill University Health Centre-Hospital, Montreal

G1V 4G5

Institut universitaire de Cardiologie et de Pneumologie de Quebec-Hospital, Ste-Foy

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY

NCT05443594 - A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation | Biotech Hunter | Biotech Hunter