First-time Ablation of Atrial Fibrillation Registry

Recruiting

• Conditions: Atrial Fibrillation; Arrhythmia

• Registration Number: NCT06381245
• Lead Sponsor: Medical University of Warsaw

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.

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 Timeline

• Study Start: 2023-12-01
• Status Verified: 2024-02
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-24
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Late AF recurrence	3-12 months after ablation	Late AF recurrence

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Warsaw; 🇵🇱 Warsaw, Poland