Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06381245
Other study ID # KB/265/2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A