Multicentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery (MITRA-HR)

February 13, 2024 updated by: Nantes University Hospital

Multicentre and Randomized Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France
        • Recruiting
        • CHU Angers
        • Contact:
          • FREDERIC PINAUD, MD
        • Principal Investigator:
          • FREDERIC ROULEAU, MD
        • Principal Investigator:
          • FREDERIC PINAUD, MD
      • Annecy, France, 74370
        • Recruiting
        • CH Annecy
        • Contact:
          • Lionel MANGIN
      • Bordeaux, France
        • Recruiting
        • CHU Bordeaux
        • Contact:
          • LIONEL LEROUX, MD-PHD
      • Bordeaux, France, 33000
        • Withdrawn
        • Clinique Saint Augustin
      • Brest, France
        • Recruiting
        • CHRU Brest
        • Contact:
          • Martine Gilard, MD
      • Créteil, France
        • Recruiting
        • Hopital Henri Mondor Aphp
        • Contact:
          • EMMANUEL TEIGER
      • Grenoble, France
        • Recruiting
        • CHU Grenoble
        • Contact:
          • OLIVIER CHAVANON, MD-PHD
        • Principal Investigator:
          • OLIVIER CHAVANON, MD-PHD
        • Principal Investigator:
          • CAROLE SAUNIER, MD
      • Le Plessis-Robinson, France
        • Recruiting
        • Centre Chirurgical Marie Lannelongue
        • Contact:
          • SAID GHOSTINE, MD
      • Lille, France, 59000
        • Recruiting
        • CHRU Lille
        • Contact:
          • ERIC VAN BELLE
      • Lille, France, 59000
        • Recruiting
        • Hopital Prive Le Bois Lille
        • Contact:
          • Antoine JEU
      • Lyon, France
        • Recruiting
        • CHU LYON
        • Contact:
          • JEAN-FRANCOIS OBADIA, MD-PHD
      • Lyon, France, 69009
        • Recruiting
        • Clinique de la Sauvegarde
        • Contact:
          • FRANCK SIBELLAS
      • Marseille, France
        • Active, not recruiting
        • Hôpital La Timone
      • Marseille, France
        • Active, not recruiting
        • Hôpital St Joseph
      • Marseille, France, 13009
        • Withdrawn
        • Hôpital privé Clairval
      • Massy, France
        • Recruiting
        • Institut Hospitalier Jacques Cartier
        • Contact:
          • THIERRY LEFEVRE, MD
      • Montpellier, France, 34000
        • Recruiting
        • Clinique du Millénaire
        • Contact:
          • CATHERINE SPORTOUCH-DUKHAN
      • Nantes, France
        • Recruiting
        • CHU Nantes
        • Contact:
          • PATRICE GUERIN, MD-PHD
        • Sub-Investigator:
          • THOMAS SENAGE, MD
        • Sub-Investigator:
          • NICOLAS PIRIOU, MD
      • Paris, France
        • Recruiting
        • Hôpital Européen Georges Pompidou
        • Contact:
          • NICOLE KARAM, MD-PHD
      • Paris, France
        • Recruiting
        • Institut Mutualiste Montsouris
        • Contact:
          • CHRISTELLE DIAKOV
      • Paris, France
        • Recruiting
        • Hopital Bichat
        • Contact:
          • DOMINIQUE HIMBERT, MD
      • Paris, France
        • Recruiting
        • Hôpital La Pitié Salpêtrière
        • Contact:
          • JEAN-PHILIPPE COLLET
      • Poitiers, France
        • Enrolling by invitation
        • CHU Poitiers
      • Rennes, France
        • Recruiting
        • CHU Rennes
        • Contact:
          • GUILLAUME LEURENT
      • Rouen, France
        • Enrolling by invitation
        • Chu de Rouen
      • Saint-Denis, France
        • Recruiting
        • Centre Cardiologique du Nord
        • Contact:
          • MOHAMMED NEJJARI
        • Principal Investigator:
          • MOHAMMED NEJJARI
        • Principal Investigator:
          • DAVID ATTIAS
      • Saint-Étienne, France, 42277
        • Recruiting
        • CHU Saint Etienne
        • Contact:
          • ROMAIN PIERRARD, MD
      • Strasbourg, France
        • Recruiting
        • Hopital Civil Strasbourg
        • Contact:
          • PATRICK OHLMANN
      • Toulouse, France
        • Recruiting
        • Clinique PASTEUR
        • Contact:
          • DIDIER TCHETCHE
      • Toulouse, France
        • Recruiting
        • Hopital Rangueil
        • Contact:
          • THIBAULT LHERMUSIER
      • Tours, France
        • Recruiting
        • CHRU Tours
        • Contact:
          • Christophe Saint Etienne
      • Villeurbanne, France, 69100
        • Recruiting
        • Clinique du Tonkin
        • Contact:
          • DIDIER CHAMPAGNAC
  • Monaco
      • Monaco, Monaco
        • Withdrawn
        • Centre Cardio-Thoracique de Monaco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW
percutaneous mitral valve repair Percutaneous MitraClip Device Implantation
Other Names:
  • MITRACLIP
Active Comparator: cardiac surgery
mitral valve repair in first intervention, valve replacement if repair not feasible
Procedure: cardiac surgery
mitral valve repair or mitral valve remplacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6, 12 and 24 months
all-cause mortality
Time Frame: 30 days and 6, 12 and 24 months
Rate of global mortality (all-causes)
30 days and 6, 12 and 24 months
cardiovascular mortality
Time Frame: 30 days and 6, 12 and 24 months
Rate of cardiovascular mortality
30 days and 6, 12 and 24 months
unplanned heart failure rehospitalization
Time Frame: 6, 12 and 24 months
Rate of unplanned heart failure rehospitalization
6, 12 and 24 months
unplanned rehospitalization rate for cardiovascular reasons
Time Frame: 30 days 6, 12 and 24 months
Rate of unplanned rehospitalization for cardiovascular reasons
30 days 6, 12 and 24 months
mitral valve reintervention
Time Frame: 30 days 6, 12 and 24 months
Mitral valve reintervention rate
30 days 6, 12 and 24 months
residual MR
Time Frame: 30 days 6, 12 and 24 months
MR (Mitral Regurgitation): grade
30 days 6, 12 and 24 months
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
baseline, 30 days and 12 months
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
baseline, 30 days and 12 months
left ventricular ejection fraction modification
Time Frame: baseline, 30 days and 12 months
Left ventricular ejection fraction
baseline, 30 days and 12 months
mitral valve remodelling
Time Frame: baseline, 30 days and 12 months
Mitral valve area and mean gradient
baseline, 30 days and 12 months
Left atrial and pulmonary artery pressures
Time Frame: baseline, 30 days and 12 months
Left atrial and pulmonary artery pressures
baseline, 30 days and 12 months
change in 6-minute Walking Test (functional evaluation)
Time Frame: baseline, 6 and 12 months
6-minute Walking Test
baseline, 6 and 12 months
surveillance of cardiac and renal function
Time Frame: baseline, 30 days, 6, 12 and 24 months
NT ProBNP or BNP creatininemia, ureamia
baseline, 30 days, 6, 12 and 24 months
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
baseline, 30 days, 6, 12 and 24 months
Cost-effectiveness analysis (economic efficiency)
Time Frame: 24 months
Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

Abbott
Ministère de la Santé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2018

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

August 25, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (Actual)

September 5, 2017

Study Record Updates

Last Update Posted (Estimated)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC17_0002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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