A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
Public ClinicalTrials.gov record NCT06455098. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06455098
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 354 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 28, 2024 (Actual)
- Primary completion
- Jul 31, 2027 (Estimated)
- Completion
- Jul 31, 2027 (Estimated)
- Last update posted
- Sep 25, 2026
2024 – 2027
United States locations
- U.S. sites
- 39
- U.S. states
- 20
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Cardiovascular Research Group | Phoenix | Arizona | 85018 | — |
| Mills Peninsula Health Services | Burlingame | California | 94010 | — |
| Cardiovascular Associates of Marin | Larkspur | California | 94939 | — |
| Hoag Memorial Hospital | Newport Beach | California | 92663 | — |
| San Diego Cardiac Center | San Diego | California | 92123 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Ascension St. Vincent's | Jacksonville | Florida | 32204 | — |
| Baptist Health Research Institute | Jacksonville | Florida | 32207 | — |
| HCA Florida Mercy Hospital | Miami | Florida | 33133 | — |
| NCH Healthcare | Naples | Florida | 34102 | — |
| Advent Health Orlando | Orlando | Florida | 32803 | — |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | — |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | — |
| Northside Hospital | Atlanta | Georgia | 30342 | — |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | — |
| NorthShore University Medical Center | Glenview | Illinois | 60026 | — |
| Johns Hopkins | Baltimore | Maryland | 21287 | — |
| Massachusetts General | Boston | Massachusetts | 02114 | — |
| Brigham And Women's Hospital | Boston | Massachusetts | 02115 | — |
| Beaumont Health Systems | Royal Oak | Michigan | 48073 | — |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55414 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| New Mexico Heart Institute | Albuquerque | New Mexico | 87102 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| New York Presbyterian - Weill Cornell Medical Ctr | New York | New York | 10065 | — |
| Lenox Hill Hospital | New York | New York | 10075 | — |
| St Francis Hospital | Roslyn | New York | 11576 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| WakeMed Heart & Vascular | Raleigh | North Carolina | 27610 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| York Hospital | York | Pennsylvania | 17403 | — |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | — |
| Texas Heart Institute | Houston | Texas | 77030 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| Inova Fairfax Medical Campus- Inova Heart and Vascular Institute | Falls Church | Virginia | 22042 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06455098, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 25, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06455098 live on ClinicalTrials.gov.