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AzTrials

Mitral RegurgitationMITRA-HRNCT03271762

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

A study testing percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW and cardiac surgery in people with Mitral Regurgitation, run by Nantes University Hospital at 31 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mitral Regurgitation
What is being tested?
percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW and cardiac surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
31 sitesFrance
Study dates
2 Mar 2018to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 31Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

France31 sites

  • Chu Angers

    Angers

  • Ch Annecy

    Annecy, 74370

  • Chu Bordeaux

    Bordeaux

  • Chru Brest

    Brest

  • Hopital Henri Mondor Aphp

    Créteil

  • Chu Grenoble

    Grenoble

  • Centre Chirurgical Marie Lannelongue

    Le Plessis-Robinson

  • Chru Lille

    Lille, 59000

  • Hopital Prive Le Bois Lille

    Lille, 59000

  • Clinique de La Sauvegarde

    Lyon, 69009

  • CHU LYON

    Lyon

  • Hopital La Timone

    Marseille

  • Hopital St Joseph

    Marseille

  • Institut Hospitalier Jacques Cartier

    Massy

  • Clinique Du Millenaire

    Montpellier, 34000

  • Chu Nantes

    Nantes

  • Hopital Bichat

    Paris

  • Hopital Europeen Georges Pompidou

    Paris

  • Hopital La Pitie Salpetriere

    Paris

  • Institut Mutualiste Montsouris

    Paris

  • Chu Poitiers

    Poitiers

  • Chu Rennes

    Rennes

  • CHU de Rouen

    Rouen

  • CHU Félix Guyon

    Saint-Denis, 97400

  • Centre Cardiologique Du Nord

    Saint-Denis

  • Chu Saint Etienne

    Saint-Etienne, 42277

  • Hopital Civil Strasbourg

    Strasbourg

  • Clinique Pasteur

    Toulouse

  • Hopital Rangueil

    Toulouse

  • Chru Tours

    Tours

  • Clinique Du Tonkin

    Villeurbanne, 69100

Other trials in France

About this study

Official title: 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).

Being tested
percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW, cardiac surgery
Keywords
MITRACLIP, primary Mitral Regurgitation, high surgical risks
Medical subject headings
Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTWDevice

    Also called MITRACLIP

    percutaneous mitral valve repair Percutaneous MitraClip Device Implantation

  • cardiac surgeryProcedure or surgery

    mitral valve repair or mitral valve remplacement

Study groups in NCT03271762
Study groupRoleWhat they receive
MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW DeviceExperimentalMitraClip NT System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system
Receives: Device: percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW
cardiac surgeryActive comparatormitral valve repair in first intervention, valve replacement if repair not feasible
Receives: Procedure: cardiac surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (1)

  1. occurrence of a major adverse event

    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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2017
  2. Study start2 Mar 2018
  3. Primary completionDec 2026 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03271762
Sponsor's protocol ID
RC17_0002
Acronym
MITRA-HR
Status last verified
Nov 2025
First submitted
25 Aug 2017
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW and cardiac surgery in people with Mitral Regurgitation, run by Nantes University Hospital at 31 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality, unplanned hospitalizations for heart failure and mitral valve reintervention (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03271762.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.

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