Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT07021313

Run by

R&D Cardiologie

People needed

378

Starts

2025-06-20

Expected to finish

2028-06-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be scheduled for PVI with the use of the FARAPULSE catheter ablation system AND
• Have paroxysmal atrial fibrillation (PAF) documented in the last 6 months prior to enrolment OR
• Had persistent atrial fibrillation but maintained in SR or converted to paroxysmal by antiarrhythmic drugs with no more than 1 cardioversion beyond 7 days in the past

You may not qualify if…

• Cerebrovascular accident (CVA) in the last 6 months
• More than moderate valvular disease that would require intervention
• Cardiac catheter/surgical intervention in the last 3 months or scheduled
• Atrial septal defect (ASD)/ patent foramen ovale (PFO) closure in the past
• Left atrial appendage (LAA) closure in the past
• Mechanical mitral valve
• Non-adherence to oral anticoagulation in the 3 weeks prior to ablation
• Renal disease with known eGFR<45 ml
• Left atrial volume index (LAVI) >50 ml/m2 or left atrial diameter (LAD) >50 mm
• Known contra-indication for catheter ablation
• Known contra-indication for deep sedation or general anesthesia
• Known pregnancy

Where it is running

• St. Antonius Hospital — Nieuwegein, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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