The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation

NACompletedINTERVENTIONAL
Enrollment

706

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

May 15, 2023

Study Completion Date

May 15, 2023

Conditions
Paroxysmal Atrial Fibrillation
Interventions
DEVICE

FARAPULSE Pulsed Field Ablation System

Ablation using the FARAPULSE Pulsed Field Ablation System

DEVICE

RadioFrequency and Cryoballoon Ablation

Contact Force Enabled RF and Cryoballoon ablation catheters indicated for Paroxysmal Atrial Fibrillation

Trial Locations (34)

10016

NYU Langone Health_Heart Rhythm Center, New York

10029

Mount Sinai, Icahn School of Medicine, New York

10075

Northwell Health- Lenox Hill Hospital, New York

17105

UPMC Pinnacle Health Cardiovascular Institute Inc., Wormleysburg

18901

Doylestown Hospital, Doylestown

19104

Hospital of the University of Pennsylvania, Philadelphia

Penn Presbyterian Medical Center, Philadelphia

20010

MedStar Washington Hospital Center, Northwest

21287

Johns Hopkins, Baltimore

22903

University of Virginia Medical Center, Charlottesville

23298

Virginia Commonwealth University Health System, Richmond

27710

Duke University Medical Center, Durham

29406

Trident Medical Center, Charleston

29425

Medical University of South Carolina, Charleston

30322

Emory University Hospital, Atlanta

35243

Grandview Medical Center, Birmingham

35294

The University of Alabama at Birmingham, Birmingham

37205

Saint Thomas Heart at Baptist Hospital, Nashville

37212

Vanderbilt University Medical Center, Nashville

64111

Saint Luke's Hospital of Kansas City, Kansas City

68114

Nebraska Methodist Health system, Inc, Omaha

78705

St Davids_Texas Cardiac Arrhythmia Research Foundation, Austin

83712

St Luke's Regional Medical Center, Boise

85006

Banner University Medical Center, Phoenix

85258

HonorHealth Scottsdale Shea, Scottsdale

92037

Scripps Memorial Hospital La Jolla, La Jolla

94109

California Pacific Medical Center, San Francisco

94143

University of California San Francisco (UCSF), San Francisco

97225

Providence St Vincent Medical Center, Heart and Vascular Clinical Trials, Portland

98122

Swedish Medical Center Heart & Vascular Research, Seattle

02114

Massachusetts General Hospital (MGH), Boston

02215

Beth Israel Deaconess Medical Center, Boston

03102

Catholic Medical Center, Manchester

07601

Hackensack University Medical Center/Hackensack Meridian Health, Hackensack

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY

NCT04612244 - The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation | Biotech Hunter | Biotech Hunter