Pulsed field ablation registry for atrial arrhythmias in Poland.
Registry of Atrial Arrhythmia Ablation Procedures Using Pulsed Field Ablation in Poland
This project will collect information to see how well pulsed field ablation works and how safe it is for people in Poland having ablation for atrial fibrillation, atrial flutter, or atrial tachycardia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wroclaw Medical University Academic / other |
| Locations | 1 site (Wroclaw, Lower Silesian Voivodeship) |
| Trial ID | NCT07109141 on ClinicalTrials.gov |
What this trial studies
Pulsed field ablation (PFA) is a relatively new, tissue‑selective catheter technique based on irreversible electroporation that has shown safety and efficacy for pulmonary vein isolation in paroxysmal atrial fibrillation. This multicenter, nationwide registry will gather standardized clinical and procedural data from patients undergoing PFA for atrial arrhythmias outside the pulmonary veins, such as atrial flutter and atrial tachycardia. The registry will consolidate outcomes on procedural success, complications, and operator techniques to characterize real‑world use across Polish centers. Data from the registry are intended to inform best practices and support the planning of future randomized trials.
Who should consider this trial
Good fit: Adults in Poland who are undergoing pulsed field ablation for atrial arrhythmias (including atrial fibrillation, atrial flutter, or atrial tachycardia) and can give informed consent.
Not a fit: Patients who are not treated with PFA (for example those receiving conventional thermal ablation), those with ventricular arrhythmias only, or those who do not consent are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the registry could improve understanding of PFA safety and effectiveness for non‑pulmonary‑vein atrial arrhythmias and help refine techniques and patient selection.
How similar studies have performed: Previous clinical studies have shown PFA to be effective and safe for pulmonary vein isolation in paroxysmal AF, but systematic evidence for its use in other atrial arrhythmias is limited and largely anecdotal.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent obtained from the participant * Subject is undergoing ablation of an atrial arrhythmia using the PFA Exclusion Criteria: \-
Where this trial is running
Wroclaw, Lower Silesian Voivodeship
- Clinical Department of Cardio, Jan Mikulicz Radecki University Hospital in Wroclaw — Wroclaw, Lower Silesian Voivodeship, Poland (Recruiting)
Study contacts
- Study coordinator: Stanislaw Tubek, MD, PhD
- Email: stanislaw.tubek@umw.edu.pl
- Phone: +48 71 733 11 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.