Actively Recruiting
A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation
Led by Biosense Webster, Inc. · Updated on 2026-05-08
466
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).
CONDITIONS
Official 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...
- Diagnosis of symptomatic persistent atrial fibrillation lasting more than 7 days and less than 365 days confirmed by physician's note and ECGs or a 24-hour arrhythmia monitor within the past year
- Age between 18 and 80 years at consent
- Willing and able to provide informed consent
- Able and willing to follow all study testing and requirements
You will not qualify if you...
- Continuous atrial fibrillation for more than 365 days (longstanding persistent AF)
- 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 the left atrium, superior vena cava, or cavotricuspid isthmus
- Severe left atrial enlargement (diameter > 50 mm) confirmed within 180 days prior
- Left atrial thrombus within 48 hours before procedure
- Severely reduced left ventricular ejection fraction (< 40%) confirmed within 180 days prior
- Uncontrolled heart failure or NYHA Class III or IV
- History of blood clotting or bleeding problems or contraindication to anticoagulation
- Thromboembolic event or transient ischemic attack within last 180 days
- Recent coronary intervention or heart attack within 60 days
- Coronary artery bypass graft surgery within last 180 days
- Valvular heart surgery or presence of prosthetic valve
- Unstable angina in last 6 months
- Planned major heart or other surgery within 365 days post-procedure
- Significant pulmonary disease causing severe chronic symptoms
- Significant congenital heart defects or repaired defects that preclude enrollment
- Existing diagnosis of pulmonary vein stenosis
- Pre-existing hemi-diaphragmatic paralysis
- Acute illness, systemic infection, or sepsis
- Intracardiac abnormalities preventing catheter use
- Severe mitral valve regurgitation
- Implanted metal cardiac devices interfering with pulsed field energy
- Conditions preventing vascular access
- Enrollment in another investigational device or drug study
- Pregnancy, lactation, or plans to become pregnant during the study
- Life expectancy less than 365 days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
Research Team
J
Jesal Parekh
CONTACT
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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