Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
St. Antonius Hospital
RECRUITING
Nieuwegein
Contact Information
Primary
Lucas VA Boersma, MD, PhD
L.boersma@antoniusziekenhuis.nl
+31883200900
Backup
Isabelle N Bax, MD
i.bax@antoniusziekenhuis.nl
+31883200929
Time Frame
Start Date: 2025-06-20
Estimated Completion Date: 2028-06
Participants
Target number of participants: 378
Treatments
Experimental: Experimental arm, extra applications
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
Active_comparator: Control arm, standard of care
Pulmonary vein isolation will be performed with the pentaspline catheter in basket shape (4x) and flower shaped (4x) applications of the catheter.
Related Therapeutic Areas
Sponsors
Leads: R&D Cardiologie

This content was sourced from clinicaltrials.gov