Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06455098 · ClinicalTrials.gov registry record · NA
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
A NA study of Atrial Fibrillation, sponsored by Biosense Webster.
- Recruiting
- Registry status
- NA
- Development phase
- 440
- Enrollment target
- 20
- Study locations
NCT06455098 is a NA study of Atrial Fibrillation that is actively recruiting participants, run by Biosense Webster. The registered enrollment target is 440 participants, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT06455098, a NA study of Atrial Fibrillation, is actively recruiting participants, sponsored by Biosense Webster.
- RECRUITING
- Registry status
- NA
- Development phase
- 440 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DEVICE OMNYPULSE™ Catheter with the TRUPULSE Generator
Study Locations (20)
California
- Mills Peninsula Health Services - Burlingame
- Scripps Clinic/Prebys Cardiovascular Institute - La Jolla
- Cardiovascular Associates of Marin - Larkspur
- Loma Linda Medical Center - Loma Linda
- Hoag Memorial Hospital - Newport Beach
- San Diego Cardiac Center - San Diego
- California Pacific Medical Center- Sutter Health - San Francisco
- Providence Saint John s Health Center - Santa Monica
Florida
- Ascension St. Vincent's - Jacksonville
- Baptist Health Research Institute - Jacksonville
- HCA Florida Mercy Hospital - Miami
- NCH Healthcare - Naples
- Advent Health Orlando - Orlando
Georgia
- Piedmont Healthcare - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
- Northside Hospital - Atlanta
- Memorial Health University Medical Center - Savannah
Arizona
- Phoenix Cardiovascular Research Group - Phoenix
Colorado
- University of Colorado - Aurora
Connecticut
- Hartford Hospital - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2024-06-28 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06455098
The ClinicalTrials.gov registry entry for NCT06455098 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 440 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (85% lower). The listed sponsor is Biosense Webster, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which OMNYPULSE™ Catheter with the TRUPULSE Generator is the first listed.
NCT06455098 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT06455098 about?
NCT06455098 is a clinical study titled "A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)". 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 ...
What is the current status of trial NCT06455098?
This trial is currently recruiting. It is a NA study. The enrollment target is 440 participants. The study started on 2024-06-28. Estimated completion is 2026-06-30.
What conditions does trial NCT06455098 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT06455098?
The interventions under investigation include: OMNYPULSE™ Catheter with the TRUPULSE Generator (DEVICE).
Who is sponsoring clinical trial NCT06455098?
This trial is sponsored by Biosense Webster, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06455098 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atrial Fibrillation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Renal Denervation + PVI vs PVI Alone for Persistent AF
RECRUITING · NA
-
Pericardiotomy in Cardiac Surgery
RECRUITING · NA
-
CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation
RECRUITING · NA
-
The CONFORM Pivotal Trial
RECRUITING · NA
-
Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
RECRUITING · NA
-
The Fourth Left Atrial Appendage Occlusion Study
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.