Actively Recruiting
Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation
Led by R&D Cardiologie · Updated on 2025-07-01
378
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pulmonary vein isolation (PVI) by catheter ablation (CA) has become a widely accepted interventional treatment for patients with symptomatic atrial fibrillation (AF) despite anti-arrhythmic drugs (AAD). Classic thermal ablation modalities use radiofrequency energy or cryo-energy to create cardiac tissue lesions. Irreversible electroporation (IRE) using pulsed field energy (PFA) is a novel technology for cardiac tissue ablation. Initial studies have shown favorable outcome data in patients with AF treated by performing PVI using PFA. However, the freedom of AF has not yet proven superior to existing thermal ablation methods and appears similarly associated with suboptimal lesion durability, leading to electrical reconnection. The purpose of this study is to determine if freedom of atrial fibrillation may be improved by delivering more and better targeted pulsed field ablations.
CONDITIONS
Official Title
Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for pulmonary vein isolation using the FARAPULSE catheter ablation system
- Diagnosed with paroxysmal atrial fibrillation within the last 6 months OR
- Had persistent atrial fibrillation but maintained in sinus rhythm or converted to paroxysmal by antiarrhythmic drugs with no more than 1 cardioversion beyond 7 days in the past
You will not qualify if you...
- Stroke or cerebrovascular accident within the last 6 months
- More than moderate heart valve disease needing intervention
- Cardiac catheter or surgical intervention in the last 3 months or planned
- Closure of atrial septal defect or patent foramen ovale in the past
- Left atrial appendage closure in the past
- Mechanical mitral valve
- Not following oral anticoagulation in the 3 weeks before ablation
- Kidney disease with estimated glomerular filtration rate below 45 ml/min
- Large left atrium volume index over 50 ml/m2 or diameter over 50 mm
- Contraindication to catheter ablation
- Contraindication to deep sedation or general anesthesia
- Known pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Antonius Hospital
Nieuwegein, Netherlands, 3435 CM
Actively Recruiting
Research Team
L
Lucas VA Boersma, MD, PhD
CONTACT
I
Isabelle N Bax, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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