NCT06381245

Brief Summary

Atrial fibrillation (AF) is a prevalent cardiac arrhythmia affecting millions globally, with projections indicating a doubling of cases by 2050. AF is linked to heightened cardiovascular risks like stroke and increased healthcare costs. Ablation, targeting the arrhythmia substrate, is a method to manage AF, yet recurrence rates remain high (20-45% in the first year). Studies highlight the impact of comorbidities, AF characteristics, ablation techniques, and myocardial remodeling markers on AF progression and ablation efficacy. However, there's no definitive guidance on selecting these factors for predicting treatment success. The aim of this study is to investigate predictors of successful AF ablation in the following areas: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Typical duration 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 Start

First participant enrolled

December 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

August 13, 2024

Status Verified

February 1, 2024

Enrollment Period

2.3 years

First QC Date

April 18, 2024

Last Update Submit

August 12, 2024

Conditions

Atrial FibrillationArrhythmia

Keywords

Atrial fibrillationArrhythmiaPulsed field ablationRadiofrequency ablationCatheter ablationPredictionDetectionMobile HealthTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Late AF recurrence

    Late AF recurrence

    3-12 months after ablation

Secondary Outcomes (13)

  • Late recurrence of AF or atrial tachycardia or atrial flutter

    3-12 months after ablation

  • Early recurrence of AF

    <3 months after ablation

  • Early recurrence of AF or atrial tachycardia or atrial flutter

    <3 months after ablation

  • Time to AF recurrence and the impact of early recurrence on late AF recurrence

    <3 and 3-12 months after ablation

  • The superiority of monitoring using mobile health devices over traditional heart rhythm monitoring

    3 months after ablation

  • +8 more secondary outcomes

Interventions

PPG-based remote heart rhythm/rate monitoringDIAGNOSTIC_TEST

PPG-based remote heart rhythm/rate monitoring

ECG-based remote heart rhythm/rate monitoringDIAGNOSTIC_TEST

ECG-based remote heart rhythm/rate monitoring

Transthoracic and transesophageal echocardiography examinationDIAGNOSTIC_TEST

Transthoracic and transesophageal echocardiography examination

Liver ultrasound examinationDIAGNOSTIC_TEST

Liver ultrasound examination

Rotational angiography with three-dimensional reconstructionDIAGNOSTIC_TEST

Rotational angiography with three-dimensional reconstruction

Blood-derived biomarker analysisDIAGNOSTIC_TEST

Blood-derived biomarker analysis

Mobile health-based spirometryDIAGNOSTIC_TEST

Mobile health-based spirometry

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing first-time ablation (radiofrequency or pulsed field)

You may qualify if:

  • paroxysmal or persistent AF
  • first-time ablation of AF

You may not qualify if:

  • patients unable to give informed consent
  • serious health condition existing before ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw

Warsaw, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Monika Gawałko, MD, PhD

    1st Department of Cardiology, Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

  • Paweł Balsam, MD, PhD

    1st Department of Cardiology, Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monika Gawałko, MD, PhD

CONTACT

22 599 19 58monika.gawalko@wum.edu.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 24, 2024

Study Start

December 1, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

August 13, 2024

Record last verified: 2024-02

Locations

PL(1)