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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: Recruiting NA study of Atrial Fibrillation, sponsored by Biosense Webster.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Number of participants with PAEs (within 7 days following the ablation procedure unless otherwise indicated) will be reported. PAEs will include the following adverse events: esophageal perforating complications (atrio-esophageal fistula, esophago-pericardial fistula), phrenic nerve paralysis (permanent), cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembol

Conditions Studied

Atrial Fibrillation

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

FieldValue
Enrollment Target 440 participants
Start Date 2024-06-28
Est. Completion 2026-06-30
Phase NA
Biosense Webster

18 total trials

What NCT06455098 shows while recruiting

NCT06455098 is an interventional study that assigns participants to a tested intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (85% lower).

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 names 20 study sites across 6 states, led by 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.

Where NCT06455098's enrollment target sits among peer trials

440 66th of 202 higher than 137 of 202 other Atrial Fibrillation trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06455098

Source: ClinicalTrials.gov NCT06455098, the US trial registry maintained by the National Library of Medicine. NCT06455098 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.