Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter

Status: Recruiting
Location: See all (46) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Diagnosed with symptomatic paroxysmal AF with:

‣ At least two symptomatic AF episodes within last six months from enrollment

⁃ At least one electrocardiographically documented AF episode within twelve months prior to enrollment

• Failed at least one Class I or Class III antiarrhythmic drug

• Willing and capable to provide consent

• Able and willing to comply with all pre-, post- and follow-up testing and requirements

Locations
United States
Arizona
Phoenix Cardiovascular Research Group
RECRUITING
Phoenix
California
Mills Peninsula Health Services
RECRUITING
Burlingame
Scripps Clinic/Prebys Cardiovascular Institute
WITHDRAWN
La Jolla
Cardiovascular Associates of Marin
RECRUITING
Larkspur
Loma Linda Medical Center
NOT_YET_RECRUITING
Loma Linda
Hoag Memorial Hospital
RECRUITING
Newport Beach
San Diego Cardiac Center
RECRUITING
San Diego
California Pacific Medical Center- Sutter Health
WITHDRAWN
San Francisco
Providence Saint John s Health Center
WITHDRAWN
Santa Monica
Colorado
University of Colorado
RECRUITING
Aurora
Connecticut
Hartford Hospital
RECRUITING
Hartford
Florida
Ascension St. Vincent's
RECRUITING
Jacksonville
Baptist Health Research Institute
RECRUITING
Jacksonville
HCA Florida Mercy Hospital
RECRUITING
Miami
NCH Healthcare
RECRUITING
Naples
Advent Health Orlando
RECRUITING
Orlando
Georgia
Emory Saint Joseph's Hospital
RECRUITING
Atlanta
Northside Hospital
RECRUITING
Atlanta
Piedmont Healthcare
RECRUITING
Atlanta
Memorial Health University Medical Center
RECRUITING
Savannah
Illinois
NorthShore University Medical Center
RECRUITING
Glenview
Massachusetts
Brigham And Women's Hospital
RECRUITING
Boston
Massachusetts General
RECRUITING
Boston
Maryland
Johns Hopkins
RECRUITING
Baltimore
Michigan
Beaumont Health Systems
RECRUITING
Royal Oak
Minnesota
Minneapolis Heart Institute
RECRUITING
Minneapolis
North Carolina
WakeMed Heart & Vascular
RECRUITING
Raleigh
New Jersey
Morristown Medical Center
RECRUITING
Morristown
New Mexico
New Mexico Heart Institute
RECRUITING
Albuquerque
New York
Lenox Hill Hospital
RECRUITING
New York
Mount Sinai School of Medicine
RECRUITING
New York
New York Presbyterian - Weill Cornell Medical Ctr
RECRUITING
New York
St Francis Hospital
RECRUITING
Roslyn
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Pennsylvania
University of Pennsylvania Health System
RECRUITING
Philadelphia
York Hospital
RECRUITING
York
Texas
Texas Cardiac Arrhythmia Research Foundation
RECRUITING
Austin
Texas Heart Institute
RECRUITING
Houston
Utah
Intermountain Medical Center
RECRUITING
Murray
Virginia
Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
RECRUITING
Falls Church
Sentara Norfolk General Hospital
RECRUITING
Norfolk
Virginia Commonwealth University
RECRUITING
Richmond
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Canberra Heart Rhythm
WITHDRAWN
Garran
Royal Melbourne Hospital
RECRUITING
Parkville
Contact Information
Primary
Study Contact
rshar120@its.jnj.com
949-789-3919
Time Frame
Start Date: 2024-06-28
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 440
Treatments
Experimental: Pulsed Field (PF) Ablation System
Participants with PAF will undergo pulsed field ablation procedure with the OMNYPULSE™ catheter in combination with TRUPULSE™ generator for PVI and to deliver pulsed field (PF) energy for treatment of atrial fibrillation. Study participants will be followed for 12 months after the study index procedure.
Related Therapeutic Areas
Sponsors
Leads: Biosense Webster, Inc.

This content was sourced from clinicaltrials.gov