NCT07109141

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
51mo left

Started Aug 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Aug 2024Jul 2030

Study Start

First participant enrolled

August 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

5.9 years

First QC Date

July 31, 2025

Last Update Submit

July 31, 2025

Conditions

Atrial Fibrillation (AF)Atrial FlutterAtrial TachycardiaAblation TechniquesPulsed Field Ablation

Outcome Measures

Primary Outcomes (1)

  • Recurrence of supraventricular arrhythmia

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

    12 months

Study Arms (1)

Patients undergoing PFA ablation of atrial arrythmia

All patients undergoing PFA ablation procedure of atrial arrythmia will be invited to enter the study.

Procedure: PFA ablation procedure of atrial arrythmia

Interventions

PFA ablation procedure of atrial arrythmiaPROCEDURE

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

Patients undergoing PFA ablation of atrial arrythmia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lack of informed consent from the participant

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationAtrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Stanislaw Tubek, MD, PhD

CONTACT

+48 71 733 11 12stanislaw.tubek@umw.edu.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 7, 2025

Study Start

August 1, 2024

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Last Updated

August 7, 2025

Record last verified: 2025-07

Locations

PL(1)