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.
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
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Flutter, Atrial Tachycardia
- 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.
Poland1 site, 1 recruiting
- 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
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.
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter, Atrial Tachycardia, Ablation Techniques, Pulsed Field Ablation
- 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 group | Role | What they receive |
|---|---|---|
| Patients undergoing PFA ablation of atrial arrythmia | All 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.
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.
- First posted7 Aug 2025
- Study start1 Aug 2024
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanisław Tubek, Wroclaw Medical University
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Atrial Arrhythmia Ablation Procedures Using Pulsed Field Ablation in Poland
- ClinicalTrials.gov ID
- NCT07109141
- Acronym / sponsor ID
- PFA Registry / 435/2024
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter, Atrial Tachycardia, Ablation Techniques, Pulsed Field Ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing PFA ablation of atrial arrythmia | – | Procedure: PFA ablation procedure of atrial arrythmiaAll patients undergoing PFA ablation procedure of atrial arrythmia will be invited to enter the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lack of informed consent from the participant
Key inclusion criteria (2 listed)
- Informed consent obtained from the participant
- Subject is undergoing ablation of an atrial arrhythmia using the PFA
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFA ablation procedure of atrial arrythmiaPFA ablation procedure of atrial arrythmia accroding to the particular patients needs | Procedure or surgery | Patients undergoing PFA ablation of atrial arrythmia |
Primary outcome
Recurrence of supraventricular arrhythmia
Time frame: 12 months
Recurrence of any supraventricular arrhythmia recorded in the ECG and provided by the participant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.