Degenerative Mitral Regurgitation I34.0
Conditions
Interventions
Group 1: MitraClip® system
Group 2: Mitral valve surgery (repair or replacement)
Sponsors
Klinikdirektor, Klinik für Herz- und Gefäßchirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Severe (4+) DMR (degenerative mitral regurgitation), or 3+ DMR - NYHA Functional Class III or IV - Mitral valve anatomy should be suitable for both MitraClip® and Mitral valve surgery (repair or replacement) - Subjects meet the following conditions: Age >=18 and high or intermediate risk with STS calculated mortality (using the repair calculator) >=3% and <=10% or as determined by the local Heart Team (which should include a surgeon and a cardiologist), based on the evidence that STS risk calculator may not identify possible risk factors - Patient is operable - Signed by the subject and dated approved informed consent prior to any study related procedure - Available and able to return to study site for post-procedural follow-up examination
Exclusion criteria
Exclusion criteria: - Patient incapable to approve the informed consent or Emergency Cases - functional mitral valve pathology - evolving endocarditis or active endocarditis in the last 3 months - heavily calcified leaflets - subjects in whom transesophageal echocardiography is contraindicated - subjects in whom transseptal catheterisation is contraindicated - presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year - currently participating in the study of an investigational drug or device - untreated clinically significant CAD requiring revascularisation - any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months - prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure - concomitant and significant aortic or tricuspid valve pathology - CVA or TIA within 6 months or severe carotid stenosis (>70% assessed by Ultrasound) - contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately managed with premedication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Safety: 30-day safety superiority (ITT analysis) The study is powered to show superiority for safety of an endovascular treatment strategy with the MitraClip® as compared to a surgical treatment strategy. The primary safety endpoint is a Major Adverse Event Composite (MAE) including all-cause death, prolonged ventilation (>48h), renal failure, stroke and need for non-elective cardiovascular or thoracic surgery (defined as any kind of cardiovascular and thoracic surgery performed within 30 days from the index procedure and non anticipated prior to the procedure). The analysis of the primary safety endpoint is a test of superiority for the proportion of subjects free from the composite of safety events in the Device vs. the Surgery group at 30 days. - Efficacy: 12-month efficacy non-inferiority (ITT analysis) The study is powered to show non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® as compared to a surgical treatment strategy. The primary effectiveness endpoint is a test of non-inferiority for the proportion of responders in the Device vs. the Surgery group at 12 months. Patients are defined as responders if they are alive with at least a 1-grade improvement in NYHA Functional Class at 12 months over baseline and have not experienced a HF hospitalization within 12 months of randomization (MitraClip® procedure or Surgery). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Safety: overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) until 12 months - Efficacy: MR (Mitral Regurgitation) Severity reduction at 6 and 12 months in the MitraClip® and Surgery groups NYHA class changes at 6 and 12 months in the MitraClip® and Surgery groups Change in 6MWT (6 Minute walking test) in 6 and 12 months in the MitraClip® and Surgery groups Change in Quality of life (MLWHF and SF36) at 1, 6 and 12 months in the MitraClip® and Surgery groups Heart failure hospitalization rate in the post randomization in the MitraClip® and Surgery groups Days alive and out of hospital in the 12 months post-randomisation in the MitraClip® and Surgery groups Hospital resources utilisations: length of stay post-procedure, ICU beds occupant, need for rehabilitation services | — |
Countries
Germany, Italy, Switzerland
Contacts
Public ContactFrancesco Maisano
Klinikdirektor, Klinik für Herz- und Gefäßchirurgie
Outcome results
None listed