Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation
NCT07021313
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
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Conditions2
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NCT07021313