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PRAGUE-25 Trial. Catheter Ablation vs. AADs and Risk Factor Modification.

NCT04011800 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2023-11-14

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Catheter ablation

Pulmonary vein isolation, or additional left or right-sided atrial lesions.

COMBINATION_PRODUCT

Risk Factor Modification

dietary restriction, physical exercise, reduced alcohol intake with antiarrhythmic drugs

Sponsors & Collaborators

  • General Teaching Hospital, Prague

    collaborator OTHER

  • Brno University Hospital

    collaborator OTHER

  • Hospital Podlesi

    collaborator OTHER

  • Regional Hospital Liberec

    collaborator OTHER

  • Charles University, Czech Republic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2025-06-30
Completion
2025-12-30

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04011800 on ClinicalTrials.gov