Actively Recruiting
Comparison of Safety and Effectiveness of VARIPULSE and FARAWAVE Pulsed Field Ablation Catheters in Treating Persistent Atrial Fibrillation
Led by Biosense Webster, Inc. · Updated on 2026-06-05
466
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the VARIPULSE pulsed field ablation (PFA) catheter compared to the FDA-approved FARAWAVE PFA catheter in adults with symptomatic persistent atrial fibrillation (PsAF). PsAF is a condition characterized by a continuous irregular and rapid heartbeat lasting more than 7 days without stopping on its own. This study aims to understand how these devices work to treat this ongoing heart rhythm problem. Participants with PsAF will be randomly assigned to receive catheter ablation treatment using either the VARIPULSE catheter or the FARAWAVE catheter. After undergoing the ablation procedure, participants will be followed and monitored for up to 12 months to assess outcomes. The treatments involve specialized catheters designed to apply pulsed field energy to the heart tissue to address abnormal rhythms. Throughout the study, participants will be observed for early adverse events within 7 days after the procedure and monitored for freedom from atrial tachyarrhythmia episodes starting from day 61. Quality of life will be evaluated at baseline, 6 months, and 12 months using a specific atrial fibrillation effect questionnaire. The study includes regular testing, follow-ups, and imaging to ensure participant safety and to measure treatment impact over time.
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
Eligibility Criteria
You may qualify if you...
- Diagnosed with symptomatic persistent atrial fibrillation lasting more than 7 days and less than 365 days
- Age between 18 and 80 years at the time of consent
- Able and willing to provide informed consent
- Able and willing to comply with all study testing and follow-up requirements
You will not qualify if you...
- Atrial fibrillation lasting more than 365 days (longstanding persistent AF)
- AF 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, and cavotricuspid isthmus regions
- Severe left atrium enlargement (diameter > 50 mm) confirmed within 180 days
- Left atrial thrombus confirmed within 48 hours before procedure
- Severely reduced left ventricular ejection fraction (< 40%) confirmed within 180 days
- Uncontrolled heart failure or NYHA Class III or IV
- History of blood clotting or bleeding problems or contraindication to anticoagulation
- Thromboembolic event within past 180 days
- Recent coronary interventions or surgery within specified timeframes
- Severe mitral valve regurgitation
- Implanted metal cardiac devices that interfere with pulsed field energy
- Conditions preventing vascular access
- Current enrollment in another investigational device or drug study
- Pregnancy, lactation, or plans to become pregnant during the study
- Life expectancy less than 365 days
- Significant pulmonary disease or congenital heart anomalies
- Acute illness, infection, or sepsis
- Intracardiac abnormalities preventing catheter use
- Existing pulmonary vein stenosis or hemi-diaphragmatic paralysis
- Unstable angina within past 6 months
- Planned major cardiac or other surgery within one year after procedure
- Other conditions judged by investigator to preclude participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo catheter ablation using either the VARIPULSE or FARAWAVE pulsed field ablation catheter.
1 procedural visit (in-person)
Duration - Up to 12 months
Participants are followed for safety and effectiveness for up to 12 months after the ablation procedure.
Regular follow-up visits throughout 12 months
Trial Site Locations
Total: 11 locations
1
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
2
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Not Yet Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
5
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Not Yet Recruiting
6
Lenox Hill Hospital
New York, New York, United States, 10075
Not Yet Recruiting
7
Montefiore Medical Center
The Bronx, New York, United States, 10467
Not Yet Recruiting
8
WakeMed Hospital
Raleigh, North Carolina, United States, 27610
Not Yet Recruiting
9
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Actively Recruiting
10
Baylor Research Institute
Plano, Texas, United States, 75093
Not Yet Recruiting
11
Intermountain Medical Center
Murray, Utah, United States, 84107
Not Yet Recruiting
Research Team
J
Jesal Parekh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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