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

NCT ID: NCT07109141

Last Updated: 2025-08-07

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2030-07-01

Brief Summary

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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

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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

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Atrial Fibrillation (AF) Atrial Flutter Atrial Tachycardia Ablation Techniques Pulsed Field Ablation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Stanisław Tubek

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Department of Cardio, Jan Mikulicz Radecki University Hospital in Wroclaw

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Stanislaw Tubek, MD, PhD

Role: CONTACT

+48 71 733 11 12

Facility Contacts

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Stanislaw Tubek, MD, PhD

Role: primary

+48 71 733 11 12

Other Identifiers

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435/2024

Identifier Type: -

Identifier Source: org_study_id

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