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Clinical Trials in the Netherlands / NCT07021313
Active, not recruiting Not applicable

Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation

NCT07021313 · tracked via the Priya Life Science Netherlands tracker
Sponsor
R&D Cardiologie
Phase
Not applicable
Started
2025-06-30
Last updated
2026-08-11

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Freedom of atrial fibrillation after a 2-month blanking period up to 18 months post procedure. — Baseline, month 3, month 6, month 12, month 18
    The primary efficacy outcome will be the freedom of arrhythmias lasting \>30 seconds after a single PVI ablation procedure from the blanking period of 2 months until 18 months follow-up after ablation. Any left-sided ablation procedure after a successful index procedure will count as treatment failure. An atrioventricular (nodal) reentry tachycardia (AVNRT/AVRT), or typical right atrial flutter occurring after the index procedure, will not count as treatment failure.

Trial sites (1)

FacilityCityRegionStatus
St. Antonius Hospital Nieuwegein Netherlands

More R&D Cardiologie trials in the Netherlands

Left Atrial Appendage Occlusion for AF Patients Unable to Use Oral Anticoagulation Therapy Active, not recruiting
Evaluation of Ablation Lesions Using Cardiovascular Magnetic Resonance Imaging Recruiting

Other trials for the same condition

The Multicenter Cardiology Monitoring Platform Registry Recruiting
A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation Active, not recruiting
RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy. Active, not recruiting
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF Recruiting
ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3 Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07021313 on ClinicalTrials.gov ↗ ← All trials in the Netherlands