PRAGUE-25 Trial. Catheter Ablation vs. AADs and Risk Factor Modification.
Catheter Ablation vs. Antiarrhythmic Drugs and Risk Factor Modification. PRAGUE-25 Randomized Study
1 other identifier
interventional
212
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 atrial-fibrillation
Started May 2021
Longer than P75 for phase_3 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedNovember 14, 2023
November 1, 2023
4.2 years
June 28, 2019
November 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freeedom from atrial fibrillation and/or atrial tachycardia
An absence of any paroxysm of atrial fibrillaton or atrial tachycardia lasting then 30 second, as assessed using repeated 7-day Holter recordings
6 months after the procedure at least, and later during the follow-up
Secondary Outcomes (10)
AF burden
baseline, than 6,9,12m and every 6 months
Hospitalization for AF
12 months
A composite of stroke, cardiovascular death, or hospitalization for heart failure
12 months
MRI endpoint
baselien and 12months
Change in cardiorespiratory fitnes
baseline and at 12 months
- +5 more secondary outcomes
Study Arms (2)
Catheter ablation
ACTIVE COMPARATORPatients will undergo catheter ablation of atrial fibrillation.
Risk factor modification
EXPERIMENTALPatiemt will undergo risk factor intervention and antiarrhythmic drugs
Interventions
Pulmonary vein isolation, or additional left or right-sided atrial lesions.
dietary restriction, physical exercise, reduced alcohol intake with antiarrhythmic drugs
Eligibility Criteria
You may qualify if:
- symptomatic atrial fibrillation
- BMI ≥ 30, and
- signed informed content
You may not qualify if:
- permanent AF
- severe valve disease (significant aortic stenosis, mitral regurgitation ≥ 3)
- left ventricular ejection fraction \< 40%
- severe pulmonary hypertension (PAP \> 40 mm Hg)
- history of tachycardia-induced cardiomyopathy
- manifest coronary artery disease
- pregnancy
- left atrial size ≥ 60 mm
- indication for surgical treatment of obesity
- BMI ≥ 40
- diabetes mellitus on insulintreatment
- age ≥ 75 let
- a significant physical limitation that could affect physical activity (musculoskeletal disorders, COPD)
- life expectancy less than 2 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Charles University, Czech Republiclead
- General Teaching Hospital, Praguecollaborator
- Brno University Hospitalcollaborator
- Hospital Podlesicollaborator
- Regional Hospital Libereccollaborator
Study Sites (1)
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, 10034, Czechia
Related Publications (1)
Osmancik P, Havranek S, Bulkova V, Chovancik J, Roubicek T, Herman D, Carna Z, Tuka V, Matoulek M, Fiala M, Jiravsky O, Stregl-Hruskova S, Latinak A, Kotryova J, Jarkovsky J. Catheter ablation versus antiarrhythmic drugs with risk factor modification for treatment of atrial fibrillation: a protocol of a randomised controlled trial (PRAGUE-25 trial). BMJ Open. 2022 Jun 15;12(6):e056522. doi: 10.1136/bmjopen-2021-056522.
PMID: 35705334DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- prospective, randomized, open - label, non-inferiority study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- head of the department of cardiac arrhythmias
Study Record Dates
First Submitted
June 28, 2019
First Posted
July 9, 2019
Study Start
May 1, 2021
Primary Completion
June 30, 2025
Study Completion
December 30, 2025
Last Updated
November 14, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR, ANALYTIC CODE
- Time Frame
- Three years after the end of follow-up, data will be available
- Access Criteria
- upon a request to the principal investigator. Only for the purpose of additional analyses - subanalysis or meta-analysis with similar trials.
The primary analysis is planned after 6 monts of follow-up of the last enrolled patients. After that, an extension of follow-up for three additional years is planned according to the protocol. Study data will be shared when the follow-up extension is finished and analyzed. Data will be available upon reasonable request. Deidentified patient data will be stored at the Institute of Biostatistics and Analyses, Masaryk University, Brno, Czech Republic, and will be available after request to principal investigator for further analyses and meta-analyses.