Clinical trial NCT06381245: First-time Ablation of Atrial Fibrillation Registry
Official title: First-time Ablation of Atrial Fibrillation Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Arrhythmia
Keywords: Atrial fibrillation
Arrhythmia
Pulsed field ablation
Radiofrequency ablation
Catheter ablation
Prediction
Detection
Mobile Health
Telemedicine
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing first-time ablation (radiofrequency or pulsed field)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Late AF recurrence
timeFrame: 3-12 months after ablation
Secondary outcomes:
measure: Late recurrence of AF or atrial tachycardia or atrial flutter
timeFrame: 3-12 months after ablation
measure: Early recurrence of AF
timeFrame: <3 months after ablation
measure: Early recurrence of AF or atrial tachycardia or atrial flutter
timeFrame: <3 months after ablation
measure: Time to AF recurrence and the impact of early recurrence on late AF recurrence
timeFrame: <3 and 3-12 months after ablation
measure: The superiority of monitoring using mobile health devices over traditional heart rhythm monitoring
timeFrame: 3 months after ablation
measure: Progression or regression of AF
timeFrame: 3-12 months after ablation
measure: Modification of treatment, including antiarrhythmic treatment
timeFrame: 3-12 months after ablation
measure: AF-related quality of life and symptoms
timeFrame: Before, 3 and 12 months after ablation
measure: Periprocedural complications
timeFrame: Around ablation
measure: Heart rate variability and rate
timeFrame: <3 months after ablation
measure: Blood biomarker levels
timeFrame: Before, 3 and 12 months after ablation
measure: Ablation procedure parameters
timeFrame: At ablation
measure: Cardiac remodelling
timeFrame: Before, 3 and 12 months after ablation
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
Study officials:
affiliation: 1st Department of Cardiology, Medical University of Warsaw
name: Monika Gawałko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 1st Department of Cardiology, Medical University of Warsaw
name: Paweł Balsam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: