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

November 24, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Angers, France
        • CHU Angers
      • Annecy, France, 74370
        • CH Annecy
      • Bordeaux, France
        • CHU Bordeaux
      • Brest, France
        • CHRU Brest
      • Créteil, France
        • Hôpital Henri Mondor APHP
      • Grenoble, France
        • CHU Grenoble
      • Le Plessis-Robinson, France
        • Centre chirurgical Marie Lannelongue
      • Lille, France, 59000
        • CHRU Lille
      • Lille, France, 59000
        • Hopital Prive Le Bois Lille
      • Lyon, France
        • CHU Lyon
      • Lyon, France, 69009
        • Clinique de la Sauvegarde
      • Marseille, France
        • Hôpital La Timone
      • Marseille, France
        • Hôpital St Joseph
      • Massy, France
        • Institut Hospitalier Jacques Cartier
      • Montpellier, France, 34000
        • Clinique du Millénaire
      • Nantes, France
        • CHU Nantes
      • Paris, France
        • Institut Mutualiste Montsouris
      • Paris, France
        • Hôpital Bichat
      • Paris, France
        • Hôpital Européen Georges Pompidou
      • Paris, France
        • Hôpital La Pitié Salpêtrière
      • Poitiers, France
        • CHU Poitiers
      • Rennes, France
        • Chu Rennes
      • Rouen, France
        • CHU de Rouen
      • Saint-Denis, France
        • Centre Cardiologique du Nord
      • Saint-Denis, France, 97400
        • CHU Felix Guyon
      • Saint-Etienne, France, 42277
        • CHU Saint Etienne
      • Strasbourg, France
        • Hopital Civil Strasbourg
      • Toulouse, France
        • Hôpital Rangueil
      • Toulouse, France
        • Clinique Pasteur
      • Tours, France
        • CHRU Tours
      • Villeurbanne, France, 69100
        • Clinique du Tonkin

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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