What is the VARIPULSE catheter studying for persistent atrial fibrillation?

The VARIPULSE catheter is being studied to compare its safety and how well it works against the FDA-approved FARAWAVE catheter in treating persistent atrial fibrillation. This trial aims to understand if the new device performs similarly or differently in managing this heart rhythm condition. 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 persistent atrial fibrillation lasting more than 7 days but less than one year may be eligible. Participants must be able to provide informed consent and comply with study procedures. People with previous ablation for atrial fibrillation or certain heart conditions are excluded. Please review eligibility criteria for more details.

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

Study-related care, including the use of the study catheters and all trial visits, is provided at no cost. Personal expenses for travel or accommodations may vary and are not guaranteed to be covered. Participants can expect to attend regular follow-up visits during the study.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 80Years

All Genders

ID07523750

Comparing Safety and Effectiveness of VARIPULSE and FARAWAVE Pulsed Field Ablation Catheters in Adults With Persistent Atrial Fibrillation

Led by Biosense Webster, Inc. · Updated on 2026-08-05

566

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the VARIPULSE pulsed field ablation PFA catheter compared to the FDA-approved FARAWAVE PFA catheter in people with symptomatic persistent atrial fibrillation PsAF, a condition characterized by continuous irregular and rapid heartbeats lasting more than 7 days without stopping on its own. This randomized controlled trial aims to compare these two devices used in catheter ablation to treat PsAF. Participants with PsAF will undergo catheter ablation using either the VARIPULSE catheter or the FARAWAVE catheter. After the ablation procedure, they will be followed for up to 12 months to monitor outcomes. The study involves two parallel groups receiving one of the two PFA devices during the ablation treatment. During the study, participants will be assessed for early adverse events within 7 days after the procedure and monitored for occurrences of atrial tachyarrhythmia episodes starting from day 61 onward. Quality of life changes will also be measured at baseline and 6 months after the procedure using a specific questionnaire. Follow-up includes regular testing and monitoring to evaluate the safety and performance of the catheters over the 12-month period.

CONDITIONS

Brief Title

A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosed with symptomatic persistent atrial fibrillation lasting more than 7 days but less than 365 days
Aged 18 to 80 years at the time of consent
Able and willing to provide informed consent
Able and willing to comply with all pre-, post-, and follow-up testing and requirements

You will not qualify if you...

Continuous atrial fibrillation lasting longer than 365 days
Atrial fibrillation caused by electrolyte imbalance, thyroid disease, or reversible/non-cardiac causes
Previous surgical or catheter ablation for atrial fibrillation
Need for ablation outside left atrium, superior vena cava, or cavotricuspid isthmus regions
Severe left atrial dilatation (antero-posterior diameter over 50 mm)
Left atrial thrombus detected within 48 hours before procedure
Severely reduced left ventricular ejection fraction (less than 40%)
Uncontrolled heart failure or NYHA Class III or IV
History of blood clotting or bleeding disorders or contraindication to anticoagulation
Thromboembolic event within past 180 days
Percutaneous coronary intervention or acute myocardial infarction within past 60 days
Coronary artery bypass grafting surgery within past 180 days
Valvular cardiac surgery or prosthetic valve presence
Unstable angina within past 6 months
Planned cardiac transplantation, surgery, or major surgery within 365 days post-procedure
Significant pulmonary disease causing severe symptoms
Significant congenital anomalies or medical problems preventing enrollment
Existing diagnosis of pulmonary vein stenosis
Pre-existing hemi-diaphragmatic paralysis
Acute illness, active infection, or sepsis
Intracardiac abnormalities preventing catheter use
Severe mitral regurgitation
Implanted metal cardiac devices such as MitraClip, left atrial appendage occlusion devices, or double-coiled ICDs
Conditions preventing vascular access
Current enrollment in another investigational device or drug study
Pregnancy, lactation, or planning pregnancy during the study
Life expectancy less than 365 days

Research Team

Jesal Parekh

Josiah M Gillespie

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Comparing Safety and Effectiveness of VARIPULSE and FARAWAVE Pulsed Field Ablation Catheters in Adults With Persistent Atrial Fibrillation

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria