First-time Ablation of Atrial Fibrillation Registry (DIPE)

August 12, 2024 updated by: Medical University of Warsaw

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

AF is a multifactorial disease influenced by many possible mechanisms. This study will examine several different predictors of successful AF ablation: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers. Analysis of these factors will help determine the optimal combination of predictors of successful ablation. This combination of prognostic factors can then be used to tailor therapeutic decisions specifically to individual patients and to improve patient selection for invasive treatment. Better patient selection and choice of ablation type can help increase success rates and avoid unnecessary procedures and their associated risks.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Warsaw, Poland
        • Recruiting
        • Medical University of Warsaw
        • Sub-Investigator:
          • Piotr Lodziński, MD, PhD
        • Principal Investigator:
          • Paweł Balsam, MD, PhD
        • Sub-Investigator:
          • Maria Boszko, MD
        • Contact:
        • Principal Investigator:
          • Monika Gawałko, MD, PhD
        • Sub-Investigator:
          • Michał Marchel, MD, PhD
        • Sub-Investigator:
          • Michał Peller, MD, PhD
        • Sub-Investigator:
          • Bartosz Krzowski, MD, PhD
        • Sub-Investigator:
          • Cezary Maciejewski, MD, PhD
        • Sub-Investigator:
          • Michał Gawlik, MD
        • Sub-Investigator:
          • Alicja Skrobucha, MD
        • Sub-Investigator:
          • Mateusz Wawrzeńczyk, MD
        • Sub-Investigator:
          • Kacper Rutkowski, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late AF recurrence
Time Frame: 3-12 months after ablation
Late AF recurrence
3-12 months after ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late recurrence of AF or atrial tachycardia or atrial flutter
Time Frame: 3-12 months after ablation
Late recurrence of AF or atrial tachycardia or atrial flutter
3-12 months after ablation
Early recurrence of AF
Time Frame: <3 months after ablation
Early recurrence of AF
<3 months after ablation
Early recurrence of AF or atrial tachycardia or atrial flutter
Time Frame: <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
Time Frame: <3 and 3-12 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
Time Frame: 3 months after ablation
The superiority of monitoring using mobile health devices over traditional heart rhythm monitoring
3 months after ablation
Progression or regression of AF
Time Frame: 3-12 months after ablation
Progression of AF (from paroxysmal to persistent or persistent to permanent) or regression of AF (from persistent to paroxysmal)
3-12 months after ablation
Modification of treatment, including antiarrhythmic treatment
Time Frame: 3-12 months after ablation
Modification of treatment, including antiarrhythmic treatment
3-12 months after ablation
AF-related quality of life and symptoms
Time Frame: Before, 3 and 12 months after ablation
AF-related quality of life and symptoms
Before, 3 and 12 months after ablation
Periprocedural complications
Time Frame: Around ablation
Periprocedural complications (e.g. cardiac tamponade, vascular complications, pseudoaneurysm, arteriovenous fistula, stroke, transient ischemic attack)
Around ablation
Heart rate variability and rate
Time Frame: <3 months after ablation
Heart rate variability and rate
<3 months after ablation
Blood biomarker levels
Time Frame: Before, 3 and 12 months after ablation
Blood biomarker levels
Before, 3 and 12 months after ablation
Ablation procedure parameters
Time Frame: At ablation
Ablation procedure parameters (e.g. ablation time, procedure time, number of applications, amount of painkillers used)
At ablation
Cardiac remodelling
Time Frame: Before, 3 and 12 months after ablation
Cardiac remodelling based on transthoracic and transesophageal echocardiography parameters
Before, 3 and 12 months after ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/265/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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