Catheter Ablation vs. Antiarrhythmic Drugs and Risk Factor Modification. PRAGUE-25 Randomized Study

Who is this study for? Patients with symptomatic atrial fibrillation
What treatments are being studied? Catheter ablation
Status: Recruiting
Intervention Type: Combination product, Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia with a prevalence of 2% in general population. Incidence and prevalence of AF has been slightly increasing due to increasing age, improved ability to treat cardiac diseases, and higher incidence of obesity and other risk factors associated with AF. AF is associated with higher morbidity and mortality mainly caused by heart failure and stroke. Catheter ablation (with pulmonary vein isolation as a cornerstone) presents the most effective treatment method of AF. Recent observational studies have shown that intensive risk factor and lifestyle modifications, such as weight loss, reduced alcohol intake, and increased physical activity, are also associated with improved rhythm outocome. Head-to-head comparison of this very different methods has not been done yet. The aim of the project is to compare the effect of catheter ablation with lifestyle modification (risk factor modification) in a prospective, randomized, multicenter study on the maintenance of sinus rhythm (monitored using implantable ECG reveal), and on the progression of the fibrosis of the left ventricle.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• symptomatic atrial fibrillation

• BMI ≥ 30, and

• signed informed content

Contact Information
Primary
Pavel Osmancik
pavel.osmancik@gmail.com
00420721544447
Time Frame
Start Date: 2021-05-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 212
Treatments
Active_comparator: Catheter ablation
Patients will undergo catheter ablation of atrial fibrillation.
Experimental: Risk factor modification
Patiemt will undergo risk factor intervention and antiarrhythmic drugs
Sponsors
Collaborators: General Teaching Hospital, Prague, Regional Hospital Liberec, Brno University Hospital, Hospital Podlesi
Leads: Charles University, Czech Republic

This content was sourced from clinicaltrials.gov