Multicentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery (MITRA-HR)
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| ClinicalTrials.gov Identifier: NCT03271762 |
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Recruitment Status :
Recruiting
First Posted : September 5, 2017
Last Update Posted : September 10, 2019
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Sponsor:
Nantes University Hospital
Collaborators:
Ministère de la Santé
Abbott
Centre Cardio-Thoracique de Monaco
Information provided by (Responsible Party):
Nantes University Hospital
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Brief Summary:
The objective of the study is to demonstrate the non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® in comparison with a surgical treatment strategy in patients with severe primary mitral regurgitation judged eligible for anatomical repair with the MitraClip® or mitral valve surgery with high surgical risk.
This trial is a French and Monegasque, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years ( clinical visit at 1 month, at 6 months and 12 months, phone call at 18 months and clincial visit at 24 months).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mitral Regurgitation | Device: percutaneous mitral valve repair with MITRACLIP NT Procedure: cardiac surgery | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 330 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Multicentre and Randomized Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery |
| Actual Study Start Date : | March 2, 2018 |
| Estimated Primary Completion Date : | March 2022 |
| Estimated Study Completion Date : | June 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: MITRACLIP NT Device / MITRACLIP NTR/XTR Device
MitraClip NT System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system
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Device: percutaneous mitral valve repair with MITRACLIP NT
percutaneous mitral valve repair Percutaneous MitraClip Device Implantation
Other Name: MITRACLIP |
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Active Comparator: cardiac surgery
mitral valve repair in first intervention, valve replacement if repair not feasible
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Procedure: cardiac surgery
mitral valve repair or mitral valve remplacement |
Primary Outcome Measures :
- All-cause mortality, unplanned hospitalizations for heart failure and mitral valve reintervention [ Time Frame: 12 months ]
comparison between arms of:
- number and reason of death
- number and reason unplanned rehospitalisation for cardiovascular reasons,
- number of mitral valve reintervention
Secondary Outcome Measures :
- occurrence of a major adverse event [ Time Frame: 30 days ]all-cause death, need for non-elective cardiovascular or thoracic surgery, device or procedure-related adverse events, major bleeding complications or serious bleeding, major access site vascular complications, major cardiac structural complications, pulmonary complications (device or procedure-related), stroke and other cerebrovascular events, myocardial infarction, acute kidney injury or progression of chronic kidney disease, arrhythmias and conduction system disturbances, unplanned mitral valve surgery due to device/procedure failure or malfunction, requirement for valve replacement after valve repair failure, unplanned cardiac surgery for any cause
Other Outcome Measures:
- Overall rate of surgery related Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) Effects (SADEs) [ Time Frame: 6, 12 and 24 months ]SAEs et SADEs rate related to protocol procedure all SAEs and SADEs
- all-cause mortality [ Time Frame: 30 days and 6, 12 and 24 months ]Rate of global mortality (all-causes)
- cardiovascular mortality [ Time Frame: 30 days and 6, 12 and 24 months ]Rate of cardiovascular mortality
- unplanned heart failure rehospitalization [ Time Frame: 6, 12 and 24 months ]Rate of unplanned heart failure rehospitalization
- unplanned rehospitalization rate for cardiovascular reasons [ Time Frame: 30 days 6, 12 and 24 months ]Rate of unplanned rehospitalization for cardiovascular reasons
- mitral valve reintervention [ Time Frame: 30 days 6, 12 and 24 months ]Mitral valve reintervention rate
- residual MR [ Time Frame: 30 days 6, 12 and 24 months ]MR (Mitral Regurgitation): grade
- left and right chamber remodelling and parameters (dimension) [ Time Frame: baseline, 30 days and 12 months ]End-systolic dimension End-diastolic dimension Left atrial dimension
- left and right chamber remodelling and parameters (volume) [ Time Frame: baseline, 30 days and 12 months ]End-systolic volume End-diastolic volume Left atrial volume
- left ventricular ejection fraction modification [ Time Frame: baseline, 30 days and 12 months ]Left ventricular ejection fraction
- mitral valve remodelling [ Time Frame: baseline, 30 days and 12 months ]Mitral valve area and mean gradient
- Left atrial and pulmonary artery pressures [ Time Frame: baseline, 30 days and 12 months ]Left atrial and pulmonary artery pressures
- change in 6-minute Walking Test (functional evaluation) [ Time Frame: baseline, 6 and 12 months ]6-minute Walking Test
- surveillance of cardiac and renal function [ Time Frame: baseline, 30 days, 6, 12 and 24 months ]NT ProBNP or BNP creatininemia, ureamia
- change in Quality of Life scores [ Time Frame: baseline, 30 days, 6, 12 and 24 months ]Quality of Life EQ-5D score SF-36 score
- Cost-effectiveness analysis (economic efficiency) [ Time Frame: 24 months ]Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Primary Mitral Regurgitation grade 3+ or 4+
- Patients in class II to IV NYHA
- Mitral valve anatomy appropriate to MitraClip® therapy and mitral valve surgery
- Adult patients judged eligible for mitral valve surgery by the local heart team but at high surgical risk defined as: age ≥ 75 years and STS score ≥ 6 % or one frailty index or one major organ system compromise or one possible procedure-specific impediment (using MVARC definitions) or age < 75 years and STS score > 8 % or at least one other high-risk criterion following the MVARC definitions
- Isolated Mitral valve pathology
- If revascularization procedures are required, they must be performed more than 30 days from intervention (D0)
- Patients affiliate to social security
Non-inclusion Criteria:
- Life expectancy < 1 year due to non-cardiac conditions
- Secondary Mitral regurgitation
- Evolving endocarditis or active endocarditis or inflammatory disease in the last 3 months
- Patient who cannot tolerate procedural anticoagulation or post procedural antiplatelet regimen
- Rheumatic mitral valve disease
- Evidence of intracardiac, inferior vena cava or femoral venous thrombus
- Valve anatomy not compatible with MitraClip® implantation (cf. colum 3 table 3 page 57)
- Stroke or transient ischaemic event within 30 days before D0
- Modified Rankin Scale ≥4 disability (appendix 9)
- TAVR within 30 days before D0-Untreated, clinically significant coronary artery disease requiring revascularization
- Any percutaneous cardiovascular intervention within 30 days before D0 including ATC
- Cardiovascular surgery, or carotid surgery within 30 days before D0
- Any prior mitral valve surgery or transcatheter mitral valve procedure
- Need for any concomitant cardiac surgery including treatment of severe secondary tricuspid regurgitation in accordance with class I recommendation in 2017 ESC guidelines. Surgical treatment of mild or moderate secondary tricuspid regurgitation (Class IIa and IIb recommendations) can still be performed in the protocol according to the local heart team decison
- NYHA functional class I
- LVEF < 30%
- Primary MR grade 1 to 2
- Subjects in whom transesophageal echocardiography or transseptal catheterization are contraindicated or high-risk
- Any condition preventing the patient from completing all protocol procedures (including compliance with guidelines directed medical therapy) and follow-up visits
- Patient unable or unwilling to provide written, informed consent before study enrolment
- Pregnant or nursing women
- Vulnerable people: persons deprived of liberty; under trusteeship or under curatorship
- Participation in another trial that would interfere with this trial
Exclusion criteria
- Not eligible for a MitraClip® intervention after Core Lab evaluation
- Before randomization (D-21) the patient no longer fulfills eligibility criteria (inclusion criteria and non-inclusion criteria)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271762
Contacts
| Contact: patrice GUERIN, MD-PHD | :+377 92 16 81 63 | pguerin@ccm.mc |
Locations
Show 31 study locations
Sponsors and Collaborators
Nantes University Hospital
Ministère de la Santé
Abbott
Centre Cardio-Thoracique de Monaco
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT03271762 |
| Other Study ID Numbers: |
RC17_0002 |
| First Posted: | September 5, 2017 Key Record Dates |
| Last Update Posted: | September 10, 2019 |
| Last Verified: | August 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Nantes University Hospital:
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MITRACLIP primary Mitral Regurgitation high surgical risks |
Additional relevant MeSH terms:
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Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |