Status:
UNKNOWN
Dapagliflozin to Prevent Atrial Fibrillation Recurrence After Transcatheter Pulmonary Venous Isolation.
Lead Sponsor:
G.Gennimatas General Hospital
Collaborating Sponsors:
Attikon Hospital
Conditions:
Atrial Fibrillation Recurrent
Pulmonary Venous Isolation
Eligibility:
All Genders
18-100 years
Phase:
EARLY_PHASE1
Brief Summary
Transcatheter left atrial antral ablation, aiming at complete electrical isolation of the pulmonary veins (PVI), has become mainstay in atrial fibrillation (AF) treatment. This approach has been prove...
Eligibility Criteria
Inclusion
- Age\>18 years Atrial Fibrillation (paroxysmal or sustained); Written informed consent; Glomerular Filtration Rate (GFR) \>45 ml/min/1.73m2 (Cockroft-Gault equation)
Exclusion
- Hypertrophic cardiomyopathy (Left ventricular wall thickness ≥15mm, not explained by abnormal pressure/volume conditions); Severe mitral valve stenosis (as defined in European Guidelines); Active malignancy; Participation in other intervention studies; Pregnancy or willing of pregnancy during the follow up period Guideline Class I or equivalent indication for treatment with a SGLT2 inhibitor
- \*Eligible patients randomized in the active comparator arm will be also included in a prospective observational registry study regarding the role of SGLT2 inhibitors in post-ablation AF recurrence.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04780438
Start Date
September 1 2021
End Date
December 1 2023
Last Update
July 27 2021
Active Locations (2)
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1
Cardiology Department, Athens General Hospital "G. Gennimatas", Athens, Greece
Athens, Greece, 11527
2
2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece.
Athens, Greece, 12462