Informations générales (source: ClinicalTrials.gov)
Multicentre and Randomized Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery (MITRA-HR)
Interventional
N/A
Nantes University Hospital (Voir sur ClinicalTrials)
mars 2018
mai 2028
05 avril 2025
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).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bichat | Marina URENA, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Europeen Georges Pompidou | NICOLE KARAM, MD-PHD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital La Pitié-Salpêtrière | OLIVIER BARTHELEMY | Contact (sur clinicalTrials) | |||
| CENTRE CARDIOLOGIQUE DU NORD | MOHAMMED NEJJARI | Contact (sur clinicalTrials) | |||
| CENTRE IMAGERIE MARIE LANNELONGUE | SAID GHOSTINE, MD | Contact (sur clinicalTrials) | |||
| IMAGERIE MEDICALE JACQUES CARTIER | Mariama AKODAD, MD | Contact (sur clinicalTrials) | |||
| INSTITUT MUTUALISTE MONTSOURIS | CHRISTELLE DIAKOV | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Ch Annecy - 74370 - Annecy - France | Lionel MANGIN | Contact (sur clinicalTrials) | |||
| Chru Brest - Brest - France | Romain DIDIER, MD | Contact (sur clinicalTrials) | |||
| Chru Tours - Tours - France | CHRISTOPHE SAINT ETIENNE | Contact (sur clinicalTrials) | |||
| Chu Angers - Angers - France | FREDERIC PINAUD, MD | Contact (sur clinicalTrials) | |||
| CHU LYON - Lyon - France | JEAN-FRANCOIS OBADIA, MD-PHD | Contact (sur clinicalTrials) | |||
| Chu Rennes - Rennes - France | GUILLAUME LEURENT | Contact (sur clinicalTrials) | |||
| Clinique de La Sauvegarde - 69009 - Lyon - France | FRANCK SIBELLAS | Contact (sur clinicalTrials) | |||
| Clinique Du Millenaire - 34000 - Montpellier - France | CATHERINE SPORTOUCH-DUKHAN | Contact (sur clinicalTrials) | |||
| Clinique Du Tonkin - 69100 - Villeurbanne - France | Oualid ZOUAGHI | Contact (sur clinicalTrials) | |||
| Clinique Pasteur - Toulouse - France | NICOLAS DUMONTEIL | Contact (sur clinicalTrials) | |||
| Clinique Saint Augustin - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Hopital Civil Strasbourg - Strasbourg - France | PATRICK OHLMANN | Contact (sur clinicalTrials) | |||
| Hopital La Timone - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hopital Prive Clairval - 13009 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hopital Prive Le Bois Lille - 59000 - Lille - France | Samy AGHEZZAF | Contact (sur clinicalTrials) | |||
| Hopital Rangueil - Toulouse - France | THIBAULT LHERMUSIER | Contact (sur clinicalTrials) | |||
| Hopital St Joseph - Marseille - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chru Lille - 59000 - Lille - France | ERIC VAN BELLE | Contact (sur clinicalTrials) | |||
| Chu Bordeaux - Bordeaux - France | LIONEL LEROUX, MD-PHD | Contact (sur clinicalTrials) | |||
| CHU de Rouen - Rouen - France | Chadi ALUDAAT, MD-PHD | Contact (sur clinicalTrials) | |||
| CHU Félix Guyon - 97400 - Saint-Denis - France | Reza ROSSANALY, MD | Contact (sur clinicalTrials) | |||
| Chu Grenoble - Grenoble - France | OLIVIER CHAVANON, MD-PHD | Contact (sur clinicalTrials) | |||
| Chu Nantes - Nantes - France | PATRICE GUERIN, MD-PHD | Contact (sur clinicalTrials) | |||
| Chu Poitiers - Poitiers - France | ELISA LARRIEU-ARDILOUZE, MD | Contact (sur clinicalTrials) | |||
| Chu Saint Etienne - 42277 - Saint-Étienne - France | ROMAIN PIERRARD, MD | Contact (sur clinicalTrials) | |||
| Hopital Henri Mondor Aphp - Créteil - France | EMMANUEL TEIGER | Contact (sur clinicalTrials) | |||
Critères
Tous
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; or age > 80
years and judged at high risk for surgery by the local heart team
- 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)
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; or age > 80
years and judged at high risk for surgery by the local heart team
- 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)