First-time Ablation of Atrial Fibrillation Registry

NCT ID: NCT06381245

Last Updated: 2024-08-13

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

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrial Fibrillation Arrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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PPG-based remote heart rhythm/rate monitoring

PPG-based remote heart rhythm/rate monitoring

Intervention Type DIAGNOSTIC_TEST

ECG-based remote heart rhythm/rate monitoring

ECG-based remote heart rhythm/rate monitoring

Intervention Type DIAGNOSTIC_TEST

Transthoracic and transesophageal echocardiography examination

Transthoracic and transesophageal echocardiography examination

Intervention Type DIAGNOSTIC_TEST

Liver ultrasound examination

Liver ultrasound examination

Intervention Type DIAGNOSTIC_TEST

Rotational angiography with three-dimensional reconstruction

Rotational angiography with three-dimensional reconstruction

Intervention Type DIAGNOSTIC_TEST

Blood-derived biomarker analysis

Blood-derived biomarker analysis

Intervention Type DIAGNOSTIC_TEST

Mobile health-based spirometry

Mobile health-based spirometry

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monika Gawałko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

1st Department of Cardiology, Medical University of Warsaw

Paweł Balsam, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

1st Department of Cardiology, Medical University of Warsaw

Locations

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Medical University of Warsaw

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Monika Gawałko, MD, PhD

Role: CONTACT

22 599 19 58 ext. +48

Facility Contacts

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Monika Gawałko, MD, PhD

Role: primary

22 599 19 58 ext. +48

Other Identifiers

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KB/265/2023

Identifier Type: -

Identifier Source: org_study_id

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