An observational study in Atrial Fibrillation (AF), Atrial Flutter and Atrial Tachycardia, sponsored by Wroclaw Medical University. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by Wroclaw Medical University · Observational
The aim of the described project is to establish a multicenter, nationwide registry of atrial arrhythmia ablation procedures using the Pulsed Field Ablation (PFA) method. These procedures have only recently begun to be performed in several centers across Poland. With proper coordination of the registry, this will enable the consolidation of clinical data and the expansion of knowledge regarding the efficacy and safety of these procedures.
Background A relatively recent innovation in cardiac ablation is Pulsed Field Ablation (PFA), a technique based on the phenomenon of irreversible electroporation. This method is tissue-selective, affecting only myocardial cells. Clinical studies have confirmed the efficacy and safety of PFA in the treatment of paroxysmal atrial fibrillation (AF).
Although the catheters currently used for PFA are designed primarily for pulmonary vein isolation (PVI) in AF ablation, there are growing numbers of reports describing their successful application in the ablation of other arrhythmias-such as atrial flutter, atrial tachycardia, and even ventricular tachycardia. However, the efficacy of such procedures has not yet been systematically evaluated in experimental or clinical settings.
We believe that establishing a national registry documenting PFA procedures for atrial arrhythmias will provide valuable insights into the clinical efficacy, safety, and procedural techniques of this emerging treatment strategy. Furthermore, it will support the planning and design of future randomized clinical trials in this area.
Objectives The aim of the project is to establish a multicenter, nationwide registry of PFA-based ablation procedures for arrhythmias other than atrial fibrillation.
Study Design and Planned Procedures The project involves the collection of clinically relevant data from patients undergoing PFA procedures targeting arrhythmias outside the pulmonary veins.
Participation in the registry will not require any additional procedures during hospitalization beyond standard clinical care.
Patients will be followed for 12 months post-ablation. Follow-up will include telephone interviews conducted at 3, 6, and 12 months after the procedure. If necessary, based on the telephone assessment, patients may be invited for an in-person clinical evaluation at the center where the procedure was performed.
The registry will be coordinated by the Institute for Heart Diseases at the Jan Mikulicz-Radecki University Hospital in Wroclaw, Poland. Other hospitals in Poland performing PFA procedures will be invited to participate in the registry.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 500 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Wroclaw Medical University is the lead sponsor of 99 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Lack of informed consent from the participant
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients undergoing PFA ablation procedure of atrial arrythmia will be invited to enter the study.
Procedure: PFA ablation procedure of atrial arrythmia
PFA ablation procedure of atrial arrythmia accroding to the particular patients needs
Recurrence of supraventricular arrhythmia
Recurrence of any supraventricular arrhythmia recorded in the ECG and provided by the participant.
Time frame: 12 months
Plan to share: Undecided
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Wroclaw Medical University