Multicentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
NCT ID: NCT03271762
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
330 participants
INTERVENTIONAL
2018-03-02
2028-01-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW Device
MitraClip NT System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system
percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW
percutaneous mitral valve repair Percutaneous MitraClip Device Implantation
cardiac surgery
mitral valve repair in first intervention, valve replacement if repair not feasible
cardiac surgery
mitral valve repair or mitral valve remplacement
Interventions
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percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW
percutaneous mitral valve repair Percutaneous MitraClip Device Implantation
cardiac surgery
mitral valve repair or mitral valve remplacement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ministère de la Santé
UNKNOWN
Abbott
INDUSTRY
Nantes University Hospital
OTHER
Responsible Party
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Locations
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Chu Angers
Angers, , France
Ch Annecy
Annecy, , France
Chu Bordeaux
Bordeaux, , France
Chru Brest
Brest, , France
Hopital Henri Mondor Aphp
Créteil, , France
Chu Grenoble
Grenoble, , France
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, , France
Chru Lille
Lille, , France
Hopital Prive Le Bois Lille
Lille, , France
Clinique de La Sauvegarde
Lyon, , France
CHU LYON
Lyon, , France
Hopital La Timone
Marseille, , France
Hopital St Joseph
Marseille, , France
Institut Hospitalier Jacques Cartier
Massy, , France
Clinique Du Millenaire
Montpellier, , France
Chu Nantes
Nantes, , France
Hopital Bichat
Paris, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital La Pitie Salpetriere
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Chu Poitiers
Poitiers, , France
Chu Rennes
Rennes, , France
CHU de Rouen
Rouen, , France
CHU Félix Guyon
Saint-Denis, , France
Centre Cardiologique Du Nord
Saint-Denis, , France
Chu Saint Etienne
Saint-Etienne, , France
Hopital Civil Strasbourg
Strasbourg, , France
Clinique Pasteur
Toulouse, , France
Hopital Rangueil
Toulouse, , France
Chru Tours
Tours, , France
Clinique Du Tonkin
Villeurbanne, , France
Countries
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Other Identifiers
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RC17_0002
Identifier Type: -
Identifier Source: org_study_id
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