Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation
- Conditions
- Cardiovascular Diseases
- Interventions
- Device: Percutaneous MitraClip Device ImplantationOther: control
- Registration Number
- NCT01920698
- Lead Sponsor
- Hospices Civils de Lyon
- 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 procedure and optimal standard of care therapy) in patients with severe secondary mitral regurgitation.
This trial is a French, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12 months and 24 months).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 288
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MitraClip Device Percutaneous MitraClip Device Implantation Subjects randomized to the MitraClip Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy. Control control Patients randomized to the Control group will receive optimal therapy alone
- Primary Outcome Measures
Name Time Method All-cause mortality and unplanned hospitalizations for heart failure 1 year
- Secondary Outcome Measures
Name Time Method Change in Quality of Life score as measured by the European Quality of Life-5 Dimensions instrument. 6 months and 12 months Change in echocardiographic evaluation between baseline at 6, 12 and 24 months. 6 months, 12 months and 24 months Serious Adverse Events 30 days, 6 months, 12 months and 24 months. Any serious adverse events cardiovascular or not occurring within each group.
Change in functional evaluation 12 months Cost-effectiveness of each strategy at 12 months 12 months Cost-effectiveness of each therapeutic strategy will be assessed by the evaluation of medical costs linked to the pathology (hospitalizations, consultations, and external medical costs (biology, radiology, medications) and compared in the 2 groups during the first 12 months of follow up.
All-cause mortality, cardiac mortality 30 days, 6 months, 12 months, and 24 months. Survival with no major cardiovascular events 30 days, 6 months, 12 months, and 24 months. Change in biomarkers (BNP levels, creatinine) at 6 months and 12 months 6 months and 12 months
Trial Locations
- Locations (40)
Hôpital Pasteur
🇫🇷Nice, France
CHU Caen
🇫🇷Caen, France
Hôpital Saint-Joseph
🇫🇷Marseille, France
CH Annecy Genevois
🇫🇷Metz-Tessy, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Aphp Hopital Bichat
🇫🇷Paris, France
Chu de Nantes
🇫🇷Nantes, France
CHRU La Cavale Blanche
🇫🇷Brest, France
Centre Chirurgical Marie Lannelongue
🇫🇷Le Plessis Robinson, France
Chu de Montpellier
🇫🇷Montpellier, France
Institut Hospitalier Jacques Cartier
🇫🇷Massy, France
Chu de Bordeaux
🇫🇷Bordeaux, France
Chu de Lille
🇫🇷Lille, France
Hopital de La Timone
🇫🇷Marseille, France
Chu de Nancy
🇫🇷Nancy, France
CHU Rouen
🇫🇷Rouen, France
Groupe Hospitalier La Salpétrière
🇫🇷Paris, France
Chu de Strasbourg
🇫🇷Strasbourg, France
Centre Cardiologique du Nord
🇫🇷Saint Denis, France
Chu de Toulouse
🇫🇷Toulouse, France
Clinique Pasteur
🇫🇷Toulouse, France
Institut Arnault Tzanck
🇫🇷Saint Laurent Du Var, France
Centre chirurgicale Ambroise Paré
🇫🇷Neuilly Sur Seine, France
Hôpital Nord
🇫🇷Saint-Étienne, France
CHRU de Tours
🇫🇷Tours, France
Clinique Cardiologique Saint Gatien
🇫🇷Tours, France
CHU d'Angers
🇫🇷Angers, France
Groupement Hospitalier Est
🇫🇷Bron, France
Chu de Besancon
🇫🇷Besancon, France
Hôpital privé Clairval
🇫🇷Marseille, France
Hôpital Gabriel Montpied
🇫🇷Clermont Ferrand, France
Hôpital privé de Parly 2
🇫🇷Le Chesnay, France
Hôpital privé le Bois
🇫🇷Lille, France
APHP Hôpital Henri Mondor
🇫🇷Creteil, France
CHU de Grenoble
🇫🇷Grenoble, France
Institut Mutualiste Montsouris
🇫🇷Paris, France
CHRU La Milétrie
🇫🇷Poitiers, France
Chu de Rennes
🇫🇷Rennes, France
Clinique du Tonkin
🇫🇷Villeurbanne, France
Clinique Du Millenaire
🇫🇷Montpellier, France