What is the BWI Pulsed Field Ablation system studying for paroxysmal atrial fibrillation?

The BWI Pulsed Field Ablation system is being studied to evaluate its safety and effectiveness in treating paroxysmal atrial fibrillation, which causes an irregular heart rhythm. Researchers want to understand how this device performs in restoring normal heart rhythm and improving quality of life over 12 months. The study is sponsored by Biosense Webster, Inc.

Who may be eligible for this atrial fibrillation clinical trial?

Adults aged 18 to 80 years with symptomatic paroxysmal atrial fibrillation who have had at least two symptomatic episodes in the last six months and failed at least one antiarrhythmic drug may be eligible. Participants must be able to consent and comply with study requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this atrial fibrillation clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel or accommodation expenses may vary and are not guaranteed to be covered. Participants should consider these possible costs when joining the trial.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 80Years

All Genders

ID06455098

Evaluating Safety and 12-Month Effectiveness of the BWI OMNYPULSE Catheter for Treating Paroxysmal Atrial Fibrillation

Led by Biosense Webster, Inc. · Updated on 2026-03-13

440

Participants Needed

Research Sites

4 weeks

Total Duration

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

Age: 18Years - 80Years

All Genders

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

Research Team

Study Contact

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