Status:
UNKNOWN
PRAGUE-25 Trial. Catheter Ablation vs. AADs and Risk Factor Modification.
Lead Sponsor:
Charles University, Czech Republic
Collaborating Sponsors:
General Teaching Hospital, Prague
Brno University Hospital
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ag...
Detailed Description
GOALS OF THE PROJECT The aim of our study is to compare the effect of the invasive strategy (catheter ablation) of atrial fibrillation with non-invasive strategy (non-amiodarone antiarrhythmic drugs w...
Eligibility Criteria
Inclusion
- Inclusion Criteria (all three must be met):
- symptomatic atrial fibrillation
- BMI ≥ 30, and
- signed informed content
- Exclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT04011800
Start Date
May 1 2021
End Date
December 30 2025
Last Update
November 14 2023
Active Locations (1)
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1
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, Czechia, 10034