First-time Ablation of Atrial Fibrillation Registry

Atrial Fibrillation Clinical Trial

— DIPE  

Official title:

First-time Ablation of Atrial Fibrillation Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381245
• Other study ID #: KB/265/2023
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: February 2024
• Source: Medical University of Warsaw
• Contact: Monika Gawalko, MD, PhD
• Phone: 22 599 19 58
• Email: monika.gawalko[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac
• Atrial Fibrillation

Intervention

Diagnostic Test:
• PPG-based remote heart rhythm/rate monitoring
PPG-based remote heart rhythm/rate monitoring
• ECG-based remote heart rhythm/rate monitoring
ECG-based remote heart rhythm/rate monitoring
• Transthoracic and transesophageal echocardiography examination
Transthoracic and transesophageal echocardiography examination
• Liver ultrasound examination
Liver ultrasound examination
• Rotational angiography with three-dimensional reconstruction
Rotational angiography with three-dimensional reconstruction
• Blood-derived biomarker analysis
Blood-derived biomarker analysis
• Mobile health-based spirometry
Mobile health-based spirometry

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

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