Registry of Atrial Arrhythmia Ablation Procedures Using Pulsed Field Ablation in Poland
NCT ID: NCT07109141
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2024-08-01
2030-07-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
OTHER
Study Groups
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Patients undergoing PFA ablation of atrial arrythmia
All patients undergoing PFA ablation procedure of atrial arrythmia will be invited to enter the study.
PFA ablation procedure of atrial arrythmia
PFA ablation procedure of atrial arrythmia accroding to the particular patients needs
Interventions
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PFA ablation procedure of atrial arrythmia
PFA ablation procedure of atrial arrythmia accroding to the particular patients needs
Eligibility Criteria
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Inclusion Criteria
* Subject is undergoing ablation of an atrial arrhythmia using the PFA
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Wroclaw Medical University
OTHER
Responsible Party
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Stanisław Tubek
MD, PhD
Locations
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Clinical Department of Cardio, Jan Mikulicz Radecki University Hospital in Wroclaw
Wroclaw, Lower Silesian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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435/2024
Identifier Type: -
Identifier Source: org_study_id
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