RecruitingNot ApplicableNCT07021313

Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation

Sponsor

R&D Cardiologie

Enrollment

378 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether delivering additional energy applications during a catheter-based heart procedure (called FARAPULSE pulsed field ablation for atrial fibrillation) can make the results more durable and reduce the chance of the heart returning to an abnormal rhythm. **You may be eligible if...** - You are scheduled to have pulmonary vein isolation (PVI) using the FARAPULSE system - You have paroxysmal (comes and goes) atrial fibrillation (irregular heartbeat) in the past 6 months, OR - You had persistent atrial fibrillation but are now in normal rhythm on medication **You may NOT be eligible if...** - You had a stroke in the last 6 months - You have moderate-to-severe heart valve disease - You had heart surgery or a cardiac catheter procedure in the last 3 months - You have had a prior closure of the left atrial appendage or a hole in your heart (ASD/PFO) - You have a mechanical mitral valve - You have not been taking blood thinners as prescribed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPulmonary vein isolation by percutaneous endocardial catheter ablation using the FARAPULSE pulsed high voltage electrical field system in patients with atrial fibrillation

Standard of care 4 pulsed electrical field applications in basket shape and 4 applications in flower shape

DEVICEPulmonary vein isolation by percutaneous endocardial catheter ablation using a pentaspline pulsed high voltage electrical field system in patients with atrial fibrillation

Experimental treatment delivering 2 pulsed electrical field applications in olive shape, 4 in basket shape and 6 applications in flower shape

Locations(1)

St. Antonius Hospital

Nieuwegein, Netherlands

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NCT07021313

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