Status:
COMPLETED
Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this trial is to compare the safety, the efficacy and the cost-effectiveness of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous MitraClip procedur...
Eligibility Criteria
Inclusion
- Age \> 18 years old
- Severe secondary mitral regurgitation characterised, according to the European guidelines and recommendations, by a regurgitant volume\>30 mL/beat or an effective regurgitant orifice\>20 mm².
- New York heart Association Class≥ II.
- Left ventricular ejection fraction between 15% and 40%
- Minimum of 1 hospitalization for heart failure within 12 months preceding randomization
- Optimal standard of care therapy for heart failure according to investigator.
- Not eligible for a mitral surgery intervention according to the Heart Team.
- Willingness to participate in the study and signed written informed consent
- Affiliation to a health insurance system or a similar system
Exclusion
- Eligible for a mitral surgery intervention according to the Heart Team.
- Primary mitral regurgitation.
- Myocardial infarction or coronary bypass grafting surgery within three months prior to randomization.
- Cardiac resynchronization therapy within three months prior to randomization.
- Cardioversion within three months prior to randomization
- Transcatheter aortic valve implantation within three months prior to randomization
- Need for any cardiovascular surgery (including registration on cardiac transplant list).
- Coronary angioplasty within one month prior to randomization.
- Previous surgical mitral valve repair.
- Renal replacement therapy.
- Active infection requiring current antibiotic therapy.
- Severe hepatic insufficiency.
- Stroke within three months prior to randomization.
- Concurrent medical condition with a life expectancy of less than 12 months.
- Uncontrolled arterial hypertension.
- Hypersensitivity to nitinol.
- Participation to another trial.
- Pregnancy.
- No affiliation to a health insurance system.
- Legal protection measure (guardianship or curatorship)
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2019
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT01920698
Start Date
November 1 2013
End Date
March 5 2019
Last Update
September 4 2025
Active Locations (40)
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1
CHU d'Angers
Angers, France, 49933
2
Chu de Besancon
Besançon, France
3
Chu de Bordeaux
Bordeaux, France
4
CHRU La Cavale Blanche
Brest, France