Status:
TERMINATED
Prevention of Atrial Fibrillation by Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Sanofi
Ministry of Health, France
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Atrial Flutter \[AFL\] is a relatively frequent arrhythmia, considered as benign, but associated with both invalidating symptoms and thromboembolic risk. The objective of the treatment consists to on ...
Detailed Description
The main goal of this study is to compare within 12 months, the effectiveness of an ACEI \[Ramipril\] versus placebo on the prevention of AFib after AFL RFA. This study is a randomized, prospective, ...
Eligibility Criteria
Inclusion
- first atrial flutter, or recurrence of atrial flutter
- affiliated or a beneficiary of a social security category
- treated by radiofrequency ablation (\< 72 h)
- having signed the inform consent form
Exclusion
- contra-indication to right catheterism
- contra-indication to angiotensin converting enzym inhibitors
- contra-indication to anticoagulation treatment
- having already a angiotensin converting enzym inhibitor treatment
- recent (\< 3 months) hearth failure with left ventricular ejection fraction \< 45%
- pregnant women or breast-feeding
- severe renal disease
- serum potassium \> 5 mmol/l
- requiring a antiarrythmic treatment
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00736294
Start Date
July 1 2008
End Date
March 1 2015
Last Update
July 28 2015
Active Locations (8)
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1
CHU de Brest
Brest, France, 29609
2
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
3
CHU de Grenoble
Grenoble, France, 38043
4
CHU de Montpellier
Montpellier, France, 34295