Actively Recruiting
Assessment of Safety and Effectiveness of BWI Pulsed Field Ablation System with OMNYPULSE Catheter for Paroxysmal Atrial Fibrillation Treatment
Led by Biosense Webster, Inc. · Updated on 2026-03-13
440
Participants Needed
46
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) system for treating people with symptomatic paroxysmal atrial fibrillation (PAF), a condition causing irregular heart rates and abnormal blood flow. This study aims to assess the safety and 12-month effectiveness of this treatment approach in managing PAF symptoms. Participants will receive a pulsed field ablation procedure using the OMNYPULSE™ catheter combined with the TRUPULSE™ generator to isolate pulmonary veins and deliver pulsed field energy to treat atrial fibrillation. After the procedure, participants will be followed for 12 months to monitor outcomes related to the treatment. During the study, participants will undergo assessments to measure adverse events within 7 days after the procedure and track freedom from atrial tachyarrhythmia episodes between day 91 and day 365. Researchers will also evaluate changes in quality of life related to atrial fibrillation from the start of the study through 12 months. Participants will be monitored throughout the follow-up period to gather safety and effectiveness data.
CONDITIONS
Brief Title
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with symptomatic paroxysmal atrial fibrillation
- At least two symptomatic atrial fibrillation episodes within the last six months
- At least one documented atrial fibrillation episode within twelve months prior to enrollment
- Failed treatment with at least one Class I or Class III antiarrhythmic drug
- Willing and able to provide consent
- Able and willing to comply with all study testing and follow-up requirements
You will not qualify if you...
- Previously diagnosed with persistent atrial fibrillation lasting more than 7 days
- Atrial fibrillation caused by electrolyte imbalance, thyroid disease, or reversible/non-cardiac causes
- Prior surgical or catheter ablation for atrial fibrillation
- Need for ablation outside pulmonary vein ostia and CTI region
- Severe left atrium enlargement (diameter over 50 mm) on recent imaging
- Left atrium thrombus detected within 48 hours before procedure
- Severely reduced left ventricular ejection fraction (less than 40%) on recent imaging
- Uncontrolled heart failure or New York Heart Association Class III or IV
- History of blood clotting or bleeding disorders or contraindications to anticoagulation
- Recent thromboembolic event within 6 months
- Recent heart attack or coronary intervention within past 2 months
- Recent coronary artery bypass surgery within past 6 months
- Valvular cardiac surgery or procedure
- Unstable angina within 6 months
- Planned major cardiac or other surgery within 12 months
- Significant lung disease causing severe chronic symptoms
- Significant congenital anomaly or medical problem preventing study participation
- Prior diagnosis of pulmonary vein stenosis
- Existing hemi diaphragmatic paralysis
- Acute illness, active infection, or sepsis
- Presence of intracardiac thrombus, tumor, or abnormality preventing catheter use
- Severe mitral valve leakage
- Implanted pacemaker, defibrillator, or metal cardiac device interfering with treatment
- Conditions preventing vascular access
- Current participation in another investigational device or drug study
- Pregnancy, lactation, or plans for pregnancy during the study
- Life expectancy less than 12 months
- Contraindications to devices used in the study as per instructions for use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (procedure day)
Participants with paroxysmal atrial fibrillation undergo a pulsed field ablation procedure using the OMNYPULSE™ catheter and TRUPULSE™ generator to treat their condition.
1 procedure visit (in-person)
Duration - 12 months
Participants are followed for 12 months after the procedure to monitor safety and effectiveness of the treatment.
Approximately monthly visits for up to 12 months
Trial Site Locations
Total: 46 locations
1
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States, 85018
Actively Recruiting
2
Mills Peninsula Health Services
Burlingame, California, United States, 94010
Actively Recruiting
3
Scripps Clinic/Prebys Cardiovascular Institute
La Jolla, California, United States, 92037
Withdrawn
4
Cardiovascular Associates of Marin
Larkspur, California, United States, 94939
Actively Recruiting
5
Loma Linda Medical Center
Loma Linda, California, United States, 92354
Withdrawn
6
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
Actively Recruiting
7
San Diego Cardiac Center
San Diego, California, United States, 92123
Actively Recruiting
8
California Pacific Medical Center- Sutter Health
San Francisco, California, United States, 94109
Withdrawn
9
Providence Saint John s Health Center
Santa Monica, California, United States, 90404
Withdrawn
10
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
11
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
12
Ascension St. Vincent's
Jacksonville, Florida, United States, 32204
Actively Recruiting
13
Baptist Health Research Institute
Jacksonville, Florida, United States, 32207
Actively Recruiting
14
HCA Florida Mercy Hospital
Miami, Florida, United States, 33133
Actively Recruiting
15
NCH Healthcare
Naples, Florida, United States, 34102
Actively Recruiting
16
Advent Health Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
17
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
Actively Recruiting
18
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
19
Northside Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
20
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Actively Recruiting
21
NorthShore University Medical Center
Glenview, Illinois, United States, 60026
Actively Recruiting
22
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
23
Massachusetts General
Boston, Massachusetts, United States, 02114
Actively Recruiting
24
Brigham And Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
25
Beaumont Health Systems
Royal Oak, Michigan, United States, 48073
Actively Recruiting
26
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
27
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
28
New Mexico Heart Institute
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
29
Mount Sinai School of Medicine
New York, New York, United States, 10029
Actively Recruiting
30
New York Presbyterian - Weill Cornell Medical Ctr
New York, New York, United States, 10065
Actively Recruiting
31
Lenox Hill Hospital
New York, New York, United States, 10075
Actively Recruiting
32
St Francis Hospital
Roslyn, New York, United States, 11576
Actively Recruiting
33
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
34
WakeMed Heart & Vascular
Raleigh, North Carolina, United States, 27610
Actively Recruiting
35
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
36
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
37
York Hospital
York, Pennsylvania, United States, 17403
Actively Recruiting
38
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Actively Recruiting
39
Texas Heart Institute
Houston, Texas, United States, 77030
Actively Recruiting
40
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
41
Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
Falls Church, Virginia, United States, 22042
Actively Recruiting
42
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
43
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
44
Royal Adelaide Hospital
Adelaide, Australia, 5000
Actively Recruiting
45
Canberra Heart Rhythm
Garran, Australia, 2605
Withdrawn
46
Royal Melbourne Hospital
Parkville, Australia, 03052
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here