A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF) (NCT06455098)
Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Phoenix Cardiovascular Research Group — Phoenix, Arizona
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (46 Sites)
Showing the first 25 of 46 sites.
- Phoenix Cardiovascular Research Group — Phoenix, Arizona
- Mills Peninsula Health Services — Burlingame, California
- Scripps Clinic/Prebys Cardiovascular Institute — La Jolla, California
- Cardiovascular Associates of Marin — Larkspur, California
- Loma Linda Medical Center — Loma Linda, California
- Hoag Memorial Hospital — Newport Beach, California
- San Diego Cardiac Center — San Diego, California
- California Pacific Medical Center- Sutter Health — San Francisco, California
- Providence Saint John s Health Center — Santa Monica, California
- University of Colorado — Aurora, Colorado
- Hartford Hospital — Hartford, Connecticut
- Ascension St. Vincent's — Jacksonville, Florida
- Baptist Health Research Institute — Jacksonville, Florida
- HCA Florida Mercy Hospital — Miami, Florida
- NCH Healthcare — Naples, Florida
- Advent Health Orlando — Orlando, Florida
- Piedmont Healthcare — Atlanta, Georgia
- Emory Saint Joseph's Hospital — Atlanta, Georgia
- Northside Hospital — Atlanta, Georgia
- Memorial Health University Medical Center — Savannah, Georgia
- NorthShore University Medical Center — Glenview, Illinois
- Johns Hopkins — Baltimore, Maryland
- Massachusetts General — Boston, Massachusetts
- Brigham And Women's Hospital — Boston, Massachusetts
- Beaumont Health Systems — Royal Oak, Michigan
📞 Contact the Study Coordinator
Phone: (949) 789-3919
Email: rshar120@its.jnj.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Atrial Fibrillation
- CHAMPION-AF Clinical Trial — Birmingham, Alabama
- Reversal of Atrial Substrate to Prevent Atrial — Calgary, Alberta
- Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients — Rochester, New York
- REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing: A Sub-Study of the REAL AF Registry — Chandler, Arizona
- Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF) — Cleveland, Ohio
- Liraglutide Effect in Atrial Fibrillation — Miami, Florida
Explore by condition: All Atrial Fibrillation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.