Pulsed-field ablation of the posterior left atrium and mitral isthmus for non-paroxysmal AF
Official title: The Acute Efficacy and Safety of Left Atrial Posterior Wall and Mitral Isthmus Ablation in Patients With Non-Paroxysmal Atrial Fibrillation
Run by Charles University, Czech Republic · NCT06801392 · Data updated 2026-11-12
This tests the Varipulse pulsed-field ablation catheter for isolating pulmonary veins and treating the left atrial posterior wall and mitral isthmus in people with non-paroxysmal atrial fibrillation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 1 site (Prague) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT06801392 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with non-paroxysmal atrial fibrillation who meet guideline indications for catheter ablation, have not had prior left atrial ablation, have acceptable kidney function, no hemolytic-prone blood disorders, and can give informed consent are ideal candidates.
✕Probably not a fit
Patients with prior left atrial ablation, chronic kidney disease stage 3 or worse, hematological disorders associated with hemolysis, or who cannot travel to the Prague site are unlikely to be eligible or to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study collecting safety and efficacy data on pulsed-field ablation (PFA) using the Varipulse variable-loop circular catheter to perform pulmonary vein isolation plus lesions on the left atrial posterior wall and mitral isthmus in patients with non-paroxysmal AF. The study documents procedural metrics such as first-pass isolation, acute reconnection, and peri-procedural complications as performed at the enrolling center. Eligible patients have guideline indications for catheter ablation and no prior left atrial ablation, while patients with significant kidney disease or hemolytic-prone blood disorders are excluded. Mapping and block-verification practices will be recorded, acknowledging that verification approaches can vary and may influence acute and long-term lesion durability.
Why it matters
Potential benefit: If successful, this approach could offer a faster and potentially safer way to achieve durable pulmonary vein isolation and additional left atrial lesion sets with less thermal injury than conventional methods.
How similar studies have gone: Early reports with pentaspline (Farawave) and variable-loop (Varipulse) PFA catheters demonstrated very high first-pass pulmonary vein isolation rates and the ADVENT trial showed comparable outcomes to radiofrequency ablation, although cases of acute or late reconnection after PFA have been reported.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. non-paroxysmal atrial fibrillation 2. an indication for catheter ablation according current guidelines 3. willingness to sign informed content. Exclusion Criteria: 1. hematological disorders that can be associated with spontaneous hemolysis 2. chronic kidney disease stage 3 or worse 3. previous left atrial ablation (either using pulsed-field or radiofrequency energy)
Where it's running
-
University Hospital Kralovske Vinohrady
Prague, Czechia Recruiting
Study contacts
- Study coordinator: Pavel Osmancik, MD, PhD
- Email: pavel.osmancik@gmail.com
- Phone: +420267 161 111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.