Cardiovascular Diseases
Conditions
Keywords
Heart Valve Diseases, Heart failure, Heart diseases, Mitral valve insufficiency
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).
Interventions
DEVICEPercutaneous MitraClip Device Implantation
MitraClip System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system
OTHERcontrol
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality and unplanned hospitalizations for heart failure | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival with no major cardiovascular events | 30 days, 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 Quality of Life score as measured by the European Quality of Life-5 Dimensions instrument. | 6 months and 12 months | — |
| All-cause mortality, cardiac mortality | 30 days, 6 months, 12 months, and 24 months. | — |
| Change in echocardiographic evaluation between baseline at 6, 12 and 24 months. | 6 months, 12 months and 24 months | — |
| Change in biomarkers (BNP levels, creatinine) at 6 months and 12 months | 6 months and 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. |
| Change in functional evaluation | 12 months | — |
Countries
France
Outcome results
None listed