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Atrial Fibrillation (AF)PFA RegistryNCT07109141

Registry of Atrial Arrhythmia Ablation Procedures Using Pulsed Field Ablation in Poland

An observational study of Atrial Fibrillation (AF) and Atrial Flutter, run by Wroclaw Medical University at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PFA ablation procedure of atrial arrythmia
Type of treatment
Surgery or procedure
How many people
500 participants
Where
1 sitePoland
Study dates
1 Aug 2024to 1 Jul 2030
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Lack of informed consent from the participant

Who may be able to join

  • Informed consent obtained from the participant
  • Subject is undergoing ablation of an atrial arrhythmia using the PFA

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Stanislaw Tubek, MD, PhD contact

+48 71 733 11 12

stanislaw.tubek@umw.edu.pl

Poland1 site, 1 recruiting
  • Clinical Department of Cardio, Jan Mikulicz Radecki University Hospital in Wroclaw

    Wroclaw, Lower Silesian Voivodeship, 50-556

    Stanislaw Tubek, MD, PhD, +48 71 733 11 12, stanislaw.tubek@umw.edu.pl

    Recruiting

Other trials in Poland

About this study

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.

Read the detailed description

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.

Being tested
PFA ablation procedure of atrial arrythmia
Medical subject headings
Atrial Fibrillation, Atrial Flutter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PFA ablation procedure of atrial arrythmiaProcedure or surgery

    PFA ablation procedure of atrial arrythmia accroding to the particular patients needs

Study groups in NCT07109141
Study groupRoleWhat they receive
Patients undergoing PFA ablation of atrial arrythmiaAll patients undergoing PFA ablation procedure of atrial arrythmia will be invited to enter the study.
Receives: Procedure: PFA ablation procedure of atrial arrythmia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence of supraventricular arrhythmia

    Recurrence of any supraventricular arrhythmia recorded in the ECG and provided by the participant.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2025
  2. Study start1 Aug 2024
  3. Primary completion1 Jul 2030 (estimated)
  4. Study completion1 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
500 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07109141
Sponsor's protocol ID
435/2024
Acronym
PFA Registry
Status last verified
Jul 2025
First submitted
31 Jul 2025
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation (AF) and Atrial Flutter, run by Wroclaw Medical University at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stanislaw Tubek, MD, PhD (+48 71 733 11 12, stanislaw.tubek@umw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of supraventricular arrhythmia (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.

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