Arrhythmia, Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Arrhythmia, Pulsed field ablation, Radiofrequency ablation, Catheter ablation, Prediction, Detection, Mobile Health, Telemedicine
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.
Interventions
DIAGNOSTIC_TESTPPG-based remote heart rhythm/rate monitoring
PPG-based remote heart rhythm/rate monitoring
DIAGNOSTIC_TESTECG-based remote heart rhythm/rate monitoring
ECG-based remote heart rhythm/rate monitoring
DIAGNOSTIC_TESTTransthoracic and transesophageal echocardiography examination
Transthoracic and transesophageal echocardiography examination
DIAGNOSTIC_TESTLiver ultrasound examination
Liver ultrasound examination
DIAGNOSTIC_TESTRotational angiography with three-dimensional reconstruction
Rotational angiography with three-dimensional reconstruction
DIAGNOSTIC_TESTBlood-derived biomarker analysis
Blood-derived biomarker analysis
DIAGNOSTIC_TESTMobile health-based spirometry
Mobile health-based spirometry
Sponsors
Medical University of Warsaw
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late AF recurrence | 3-12 months after ablation | Late AF recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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) |
| Modification of treatment, including antiarrhythmic treatment | 3-12 months after ablation | Modification of treatment, including antiarrhythmic treatment |
| AF-related quality of life and symptoms | Before, 3 and 12 months after ablation | AF-related quality of life and symptoms |
| 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 |
| Blood biomarker levels | Before, 3 and 12 months after ablation | Blood biomarker levels |
| Ablation procedure parameters | At ablation | Ablation procedure parameters (e.g. ablation time, procedure time, number of applications, amount of painkillers used) |
| Cardiac remodelling | Before, 3 and 12 months after ablation | Cardiac remodelling based on transthoracic and transesophageal echocardiography parameters |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORMonika Gawałko, MD, PhD
1st Department of Cardiology, Medical University of Warsaw
PRINCIPAL_INVESTIGATORPaweł Balsam, MD, PhD
1st Department of Cardiology, Medical University of Warsaw
Outcome results
None listed