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Completed

NCT Number: NCT06381245

First-time Ablation of Atrial Fibrillation Registry

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Warsaw

Warsaw, Poland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PPG-based remote heart rhythm/rate monitoring

Diagnostic Test

PPG-based remote heart rhythm/rate monitoring

ECG-based remote heart rhythm/rate monitoring

Diagnostic Test

ECG-based remote heart rhythm/rate monitoring

Transthoracic and transesophageal echocardiography examination

Diagnostic Test

Transthoracic and transesophageal echocardiography examination

Liver ultrasound examination

Diagnostic Test

Liver ultrasound examination

Rotational angiography with three-dimensional reconstruction

Diagnostic Test

Rotational angiography with three-dimensional reconstruction

Blood-derived biomarker analysis

Diagnostic Test

Blood-derived biomarker analysis

Mobile health-based spirometry

Diagnostic Test

Mobile health-based spirometry

Primary outcomes

  1. Late AF recurrence

    Time frame: 3-12 months after ablation

    Late AF recurrence

Secondary outcomes

  1. 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

  2. Early recurrence of AF

    Time frame: <3 months after ablation

    Early recurrence of AF

  3. 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

  4. 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

  5. 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

  6. 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)

  7. Modification of treatment, including antiarrhythmic treatment

    Time frame: 3-12 months after ablation

    Modification of treatment, including antiarrhythmic treatment

  8. AF-related quality of life and symptoms

    Time frame: Before, 3 and 12 months after ablation

    AF-related quality of life and symptoms

  9. Periprocedural complications

    Time frame: Around ablation

    Periprocedural complications (e.g. cardiac tamponade, vascular complications, pseudoaneurysm, arteriovenous fistula, stroke, transient ischemic attack)

  10. Heart rate variability and rate

    Time frame: <3 months after ablation

    Heart rate variability and rate

  11. Blood biomarker levels

    Time frame: Before, 3 and 12 months after ablation

    Blood biomarker levels

  12. Ablation procedure parameters

    Time frame: At ablation

    Ablation procedure parameters (e.g. ablation time, procedure time, number of applications, amount of painkillers used)

  13. Cardiac remodelling

    Time frame: Before, 3 and 12 months after ablation

    Cardiac remodelling based on transthoracic and transesophageal echocardiography parameters

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Acronym: DIPE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2024
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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