More and better-targeted pulsed field ablation to make pulmonary vein isolation last longer

Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation

This study will test whether giving extra and better-targeted pulsed field ablations during pulmonary vein isolation reduces atrial fibrillation coming back in people with paroxysmal or drug-controlled persistent AF.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 378 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: R&D Cardiologie (Academic / other)
• Locations: 1 site (Nieuwegein)
• Trial ID: NCT07021313 on ClinicalTrials.gov

What this trial studies

This randomized, controlled study compares a standard pulsed field pulmonary vein isolation (PVI) approach with a modified regimen that delivers additional and differently shaped applications at each pulmonary vein using the FARAPULSE system. Patients are randomized 1:1 with block size 4 to receive either the control pattern (4 basket and 4 flower applications per vein) or the intensified pattern (2 olive, 4 basket, and 6 flower applications per vein), with all other procedural steps identical. The trial enrolls patients scheduled for PVI who have paroxysmal AF or persistent AF converted/controlled by drugs, and excludes those with recent stroke, significant valvular disease, severe renal impairment, very large left atria, or other contraindications. The primary goal is to determine if the intensified pulsed field delivery improves lesion durability and reduces AF recurrence compared with the usual application pattern.

Who should consider this trial

Good fit: Ideal candidates are adults scheduled for PVI with the FARAPULSE catheter who have paroxysmal AF or persistent AF converted/controlled by antiarrhythmic drugs and meet the procedure's safety criteria.

Not a fit: Patients with recent cerebrovascular accident, more than moderate valvular disease requiring intervention, severe renal dysfunction, very large left atria, prior LAA or ASD/PFO closure, mechanical mitral valve, or other contraindications to catheter ablation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could produce more durable pulmonary vein isolation, lowering AF recurrence and reducing the need for repeat ablations.

How similar studies have performed: Early studies of pulsed field ablation have shown favorable safety and procedural outcomes, but freedom from AF has not yet clearly surpassed thermal methods and lesion durability remains a common challenge.

Eligibility criteria

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

Where this trial is running

Nieuwegein

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

Study contacts

• Principal investigator: Lucas VA Boersma, MD, PhD — St. Antonius Hospital
• Study coordinator: Lucas VA Boersma, MD, PhD

Conditions Atrial Fibrillation; Pulsed Field Ablation