A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

NARecruitingINTERVENTIONAL
Enrollment

440

Participants

Timeline

Start Date

June 28, 2024

Primary Completion Date

May 30, 2026

Study Completion Date

May 30, 2026

Conditions
Atrial Fibrillation
Interventions
DEVICE

OMNYPULSE™ Catheter with the TRUPULSE Generator

OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation.

Trial Locations (46)

2605

WITHDRAWN

Canberra Heart Rhythm, Garran

5000

RECRUITING

Royal Adelaide Hospital, Adelaide

10029

RECRUITING

Mount Sinai School of Medicine, New York

10065

RECRUITING

New York Presbyterian - Weill Cornell Medical Ctr, New York

10075

RECRUITING

Lenox Hill Hospital, New York

10467

RECRUITING

Montefiore Medical Center, The Bronx

11576

RECRUITING

St Francis Hospital, Roslyn

17403

RECRUITING

York Hospital, York

19104

RECRUITING

University of Pennsylvania Health System, Philadelphia

21287

RECRUITING

Johns Hopkins, Baltimore

22042

RECRUITING

Inova Fairfax Medical Campus- Inova Heart and Vascular Institute, Falls Church

23298

RECRUITING

Virginia Commonwealth University, Richmond

23507

RECRUITING

Sentara Norfolk General Hospital, Norfolk

27610

RECRUITING

WakeMed Heart & Vascular, Raleigh

30309

RECRUITING

Piedmont Healthcare, Atlanta

30342

RECRUITING

Emory Saint Joseph's Hospital, Atlanta

RECRUITING

Northside Hospital, Atlanta

31404

RECRUITING

Memorial Health University Medical Center, Savannah

32204

RECRUITING

Ascension St. Vincent's, Jacksonville

32207

RECRUITING

Baptist Health Research Institute, Jacksonville

32803

RECRUITING

Advent Health Orlando, Orlando

33133

RECRUITING

HCA Florida Mercy Hospital, Miami

34102

RECRUITING

NCH Healthcare, Naples

44195

RECRUITING

Cleveland Clinic, Cleveland

48073

RECRUITING

Beaumont Health Systems, Royal Oak

55414

RECRUITING

Minneapolis Heart Institute, Minneapolis

60026

RECRUITING

NorthShore University Medical Center, Glenview

77030

RECRUITING

Texas Heart Institute, Houston

78705

RECRUITING

Texas Cardiac Arrhythmia Research Foundation, Austin

80045

RECRUITING

University of Colorado, Aurora

84107

RECRUITING

Intermountain Medical Center, Murray

85018

RECRUITING

Phoenix Cardiovascular Research Group, Phoenix

87102

RECRUITING

New Mexico Heart Institute, Albuquerque

90404

WITHDRAWN

Providence Saint John s Health Center, Santa Monica

92037

WITHDRAWN

Scripps Clinic/Prebys Cardiovascular Institute, La Jolla

92123

RECRUITING

San Diego Cardiac Center, San Diego

92354

NOT_YET_RECRUITING

Loma Linda Medical Center, Loma Linda

92663

RECRUITING

Hoag Memorial Hospital, Newport Beach

94010

RECRUITING

Mills Peninsula Health Services, Burlingame

94109

WITHDRAWN

California Pacific Medical Center- Sutter Health, San Francisco

94939

RECRUITING

Cardiovascular Associates of Marin, Larkspur

06102

RECRUITING

Hartford Hospital, Hartford

02114

RECRUITING

Massachusetts General, Boston

02115

RECRUITING

Brigham And Women's Hospital, Boston

07960

RECRUITING

Morristown Medical Center, Morristown

03052

RECRUITING

Royal Melbourne Hospital, Parkville

All Listed Sponsors
lead

Biosense Webster, Inc.

INDUSTRY