Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation (DOPPIO)

R&D Cardiologie

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Device: Pulmonary vein isolation by percutaneous endocardial catheter ablation using the FARAPULSE pulsed high voltage electrical field system in patients with atrial fibrillation; Device: Pulmonary vein isolation by percutaneous endocardial catheter ablation using a pentaspline pulsed high voltage electrical field system in patients with atrial fibrillation

Study type: Interventional

Funder types: Other

Identifiers

NCT07021313

NL88354.100.24

Details and patient eligibility

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.

Full description

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. Patients will undergo the standard catheter ablation procedure in accordance with good clinical practice, performing pulmonary vein islolation (PVI) with the FARAPULSE cardiac ablation system. In the control group PVI will be performed with 4 basket- and 4 flower-shaped applications of the catheter, while in the study group 2 olive-, 4 basket-, and 6 flower shaped applications will be delivered at each vein. All other procedural steps will be the same between groups. Patients will be randomized in a 1:1 fashion with a block size of 4 to the study arm or the usual care (control) arm. The primary study parameter for efficacy is the freedom of atrial arrhythmias after the 2-month blanking period up to 12 months after the procedure. The secondary study outcomes include the extent and position of pulmonary vein reconnection observed during redo procedures that are performed due to arrhythmia recurrence, which constitutes a study endpoint. Furthermore, the study also evaluates arrhythmia burden after the procedure in centers that routinely use photoplethysmographic remote monitoring as standard care for all their ablation patients.

Enrollment: 378 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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378 participants in 2 patient groups

Experimental arm, extra applications

Experimental group

Description:

Pulmonary vein isolation will be performed with the pentaspline ablation catheter in an olive-shape (2x), basket shape (4x), and flower shape (6x) at each vein

Treatment:

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

Control arm, standard of care

Active Comparator group

Description:

Pulmonary vein isolation will be performed with the pentaspline catheter in basket shape (4x) and flower shaped (4x) applications of the catheter.

Treatment:

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