Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation

NAActive, not recruitingINTERVENTIONAL
Enrollment

484

Participants

Timeline

Start Date

December 28, 2023

Primary Completion Date

February 3, 2026

Study Completion Date

February 3, 2028

Conditions
Persistent Atrial Fibrillation
Interventions
DEVICE

FARAPULSE™ Pulsed Field Ablation (PFA) System

Subjects will undergo a pulsed field ablation procedure using the FARAPULSE™ Pulsed Field Ablation (PFA) System for the isolation of pulmonary veins and posterior wall.

DRUG

Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone

Anti-Arrhythmic Drugs (AADs) including, Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone will be prescribed and monitored in accordance with local clinical practice and already established guideline-directed therapy for patients with persistent atrial fibrillation (AF).

Trial Locations (64)

1127

Taipei Veterans General Hospital-Hospital, Taipei

3168

Monash Medical Centre, Clayton

4032

The Prince Charles Hospital, Chermside

5000

Royal Adelaide Hospital-Hospital, Adelaide

8036

Medizinische Univ.-Kliniken Graz-Hospital, Graz

10021

Weill Cornell Medical University, New York

10901

Good Samaritan - Suffern, Suffern

11706

Northwell Health, Bay Shore

14203

Kaleida Health, Buffalo

17403

York Hospital, York

20138

Centro Cardiologico Monzino, Milan

21287

Johns Hopkins Hospital, Baltimore

23225

Chippenham & Johnston-Willis Hospital (CJW), Richmond

27157

Wake Forest University School of Medicine, Winston-Salem

30342

Emory University Hospital, Atlanta

31404

Memorial Health University Medical Center, Savannah

32308

Tallahassee Memorial Hospital, Tallahassee

33133

HCA Florida Mercy Hospital, Miami

33614

St. Joseph's Hospital, Tampa

34239

Sarasota Memorial Hospital, Sarasota

37232

Vanderbilt University Medical Center, Nashville

38043

CHU Grenoble - Hopital Michallon, Grenoble

40503

Baptist Health Lexington, Lexington

43214

OhioHealth Research and Innovation Institute - Riverside Methodist Hospital, Columbus

44195

Cleveland Clinic, Cleveland

45242

Bethesda North Hospital, Cincinnati

46250

Community Heart and Vascular Hospital, Indianapolis

48010

Maria Cecilia Hospital SPA, Cotignola

48108

University of Michigan Hospitals, Ann Arbor

49503

Corewell Health, Grand Rapids

50266

Mercy Hospital Medical Center-Hospital, West Des Moines

52601

University of Iowa Hospitals and Clinics, West Burlington

53215

Aurora St. Luke's Medical Center, Milwaukee

55905

Mayo Clinic Foundation-Hospital, Rochester

60126

AOU delle Marche - PO GM Lancisi, Ancona

60431

Cardioangiologisches Centrum Bethanien, Frankfurt

62701

St. John's Hospital, Springfield

72401

Arrhythmia Research Group, Jonesboro

74104

Oklahoma Heart Institute, Tulsa

75701

Christus Trinity Mother Frances Health System, Tyler

76133

Staedtisches Klinikum Karlsruhe, Karlsruhe

77034

Orion Medical, Houston

78705

Texas Cardiac Arrhythmia Research, Austin

84107

Intermountain Medical Center, Murray

85006

Banner University Medical Center Phoenix, Phoenix

85018

Phoenix Cardiovascular Research Group, Phoenix

92037

Scripps Memorial Hosptial, La Jolla

93003

Cardiology Associates Medical Group, Inc, Ventura

169609

National Heart Centre Singapore, Singapore

999077

Queen Mary Hospital, Hong Kong

Prince of Wales Hospital, Shatin

35249-7333

University of Alabama at Birmingham, Birmingham

94305-5406

Stanford University Medical Center, Palo Alto

02115

Brigham and Women's Hospital, Boston

02720

Southcoast Physicians Group, Fall River

03102

Catholic Medical Center, Manchester

07652

Valley Hospital, Paramus

77555-0737

University of Texas Medical Branch, Galveston

B-8000

St. Jan, Bruges

L8L 2X2

Hamilton General Hospital, Hamilton

G1V 4G5

Institut universitaire de Cardiologie et de Pneumologie de Quebec, Québec

21 000

Klinicki Bolnicki Centar Split, Split

00133

Fondazione PTV - Policlinico Tor Vergata, Roma

Unknown

Hospital Universitario La Fe, Valencia

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY