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Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation
Sponsor: R&D Cardiologie
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
378
Start Date
2025-06-20
Completion Date
2028-06
Last Updated
2025-07-01
Healthy Volunteers
No
Conditions
Interventions
Pulmonary 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
Pulmonary 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