NCT07021313Active, not recruiting
Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 378 (estimated)
- First submitted
- 30 May 2025
- Start date
- 30 Jun 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- R&D Cardiologie
- Diseases
- Atrial fibrillation
- NCT number
- NCT07021313
What you commit to
- Study type: Interventional
- Planned participants: 378
- From 30 Jun 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Non-adherence to oral anticoagulation in the 3 weeks prior to ablation
Other illness
- More than moderate valvular disease that would require intervention
- Cardiac catheter/surgical intervention in the last 3 months or scheduled
Lab values
- Renal disease with known eGFR\<45 ml
Other
- Cerebrovascular accident (CVA) in the last 6 months
- Atrial septal defect (ASD)/ patent foramen ovale (PFO) closure in the past
- Left atrial appendage (LAA) closure in the past
- Mechanical mitral valve
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Antonius Hospital Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.