Multicentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
MITRA-HR
Multicentre and Randomized Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
1 other identifier
interventional
330
1 country
31
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2017
CompletedFirst Posted
Study publicly available on registry
September 5, 2017
CompletedStudy Start
First participant enrolled
March 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
November 26, 2025
November 1, 2025
8.8 years
August 25, 2017
November 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality, unplanned hospitalizations for heart failure and mitral valve reintervention
comparison between arms of: * number and reason of death * number and reason unplanned rehospitalisation for cardiovascular reasons, * number of mitral valve reintervention
12 months
Secondary Outcomes (1)
occurrence of a major adverse event
30 days
Other Outcomes (16)
Overall rate of surgery related Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) Effects (SADEs)
6, 12 and 24 months
all-cause mortality
30 days and 6, 12 and 24 months
cardiovascular mortality
30 days and 6, 12 and 24 months
- +13 more other outcomes
Study Arms (2)
MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW Device
EXPERIMENTALMitraClip NT System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system
cardiac surgery
ACTIVE COMPARATORmitral valve repair in first intervention, valve replacement if repair not feasible
Interventions
percutaneous mitral valve repair Percutaneous MitraClip Device Implantation
Eligibility Criteria
You may qualify if:
- 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
- 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
- +15 more criteria
You may not qualify if:
- Not eligible for a MitraClip® intervention after Core Lab evaluation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nantes University Hospitallead
- Ministère de la Santécollaborator
- Abbottcollaborator
Study Sites (31)
Chu Angers
Angers, France
Ch Annecy
Annecy, 74370, 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, 59000, France
Hopital Prive Le Bois Lille
Lille, 59000, France
Clinique de La Sauvegarde
Lyon, 69009, 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, 34000, 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, 97400, France
Centre Cardiologique Du Nord
Saint-Denis, France
Chu Saint Etienne
Saint-Etienne, 42277, France
Hopital Civil Strasbourg
Strasbourg, France
Clinique Pasteur
Toulouse, France
Hopital Rangueil
Toulouse, France
Chru Tours
Tours, France
Clinique Du Tonkin
Villeurbanne, 69100, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2017
First Posted
September 5, 2017
Study Start
March 2, 2018
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 1, 2028
Last Updated
November 26, 2025
Record last verified: 2025-11