Actively Recruiting
Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation
Led by Erasmus Medical Center · Updated on 2025-11-19
20
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
B
Biosense Webster, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The VARIFY study is designed to find out how durable pulmonary vein isolation (PVI) is after treatment with the VARIPULSE pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation (AF). AF is a common heart rhythm disorder caused by abnormal electrical signals coming from the pulmonary veins. In a PVI procedure, these veins are electrically isolated to prevent AF from recurring. Sometimes, the veins reconnect over time, which can lead to a return of arrhythmia. PFA is a new, non-thermal technology that uses short electrical pulses to safely and precisely treat heart tissue, reducing the risk of damage to nearby structures. The VARIPULSE system is one of these new PFA platforms. In this study, 20 adult patients with paroxysmal AF will undergo PVI using the VARIPULSE system. After 2-3 months, each patient will have a second planned procedure to check whether the pulmonary veins remain isolated. Any reconnections found will be treated immediately. The main goal is to determine how often the pulmonary veins stay durably isolated after the initial VARIPULSE treatment. Secondary goals include assessing the amount of scar tissue in the left atrium, recording any complications, and evaluating rhythm outcomes after one year. The results will help determine how effective and reliable the VARIPULSE system is for long-term treatment of AF.
CONDITIONS
Official Title
Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of symptomatic paroxysmal atrial fibrillation
- Indicated for pulmonary vein isolation according to 2020 ESC guidelines
- Willing and able to undergo a mandatory repeat procedure 2-3 months after the first
- Age between 18 and 80 years
- Willing and able to provide informed consent
You will not qualify if you...
- Known contraindication to atrial fibrillation ablation or anticoagulation
- Previous left atrial ablation or surgical treatment for atrial fibrillation, atrial flutter, or atrial tachycardia
- Atrial fibrillation caused by electrolyte imbalance, thyroid disease, or other reversible/non-cardiac causes
- Significant structural heart disease
- History of blood clotting or bleeding diseases
- Severe kidney disease with glomerular filtration rate below 30 ml/min/1.73 m2
- Stroke or transient ischemic attack within 3 months before enrollment
- Active systemic infection
- Pregnant, breastfeeding, or women planning pregnancy during the study
- Currently enrolled in another investigational study or registry that interferes with this study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands
Actively Recruiting
Research Team
S
Sing-Chien Yap, MD, PhD
CONTACT
B
Bakhtawar K Mahmoodi, MD, PhD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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