ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 41 for:    mitraclip

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03271762
Recruitment Status : Not yet recruiting
First Posted : September 5, 2017
Last Update Posted : November 20, 2017
Sponsor:
Collaborators:
Ministère de la Santé
Abbott
Information provided by (Responsible Party):
Nantes University Hospital

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, 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).


Condition or disease Intervention/treatment Phase
Mitral Regurgitation Device: percutaneous mitral valve repair with MITRACLIP NT Procedure: cardiac surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentre and Randomized Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2023

Arm Intervention/treatment
Experimental: MITRACLIP NT 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
percutaneous mitral valve repair Percutaneous MitraClip Device Implantation
Other Name: 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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. all-cause mortality [ Time Frame: 30 days and 6, 12 and 24 months ]
    Rate of global mortality (all-causes)

  3. cardiovascular mortality [ Time Frame: 30 days and 6, 12 and 24 months ]
    Rate of cardiovascular mortality

  4. unplanned heart failure rehospitalization [ Time Frame: 6, 12 and 24 months ]
    Rate of unplanned heart failure rehospitalization

  5. unplanned rehospitalization rate for cardiovascular reasons [ Time Frame: 30 days 6, 12 and 24 months ]
    Rate of unplanned rehospitalization for cardiovascular reasons

  6. mitral valve reintervention [ Time Frame: 30 days 6, 12 and 24 months ]
    Mitral valve reintervention rate

  7. residual MR [ Time Frame: 30 days 6, 12 and 24 months ]
    MR (Mitral Regurgitation): grade

  8. 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

  9. 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

  10. left ventricular ejection fraction modification [ Time Frame: baseline, 30 days and 12 months ]
    Left ventricular ejection fraction

  11. mitral valve remodelling [ Time Frame: baseline, 30 days and 12 months ]
    Mitral valve area and mean gradient

  12. Left atrial and pulmonary artery pressures [ Time Frame: baseline, 30 days and 12 months ]
    Left atrial and pulmonary artery pressures

  13. change in 6-minute Walking Test (functional evaluation) [ Time Frame: baseline, 6 and 12 months ]
    6-minute Walking Test

  14. surveillance of cardiac and renal function [ Time Frame: baseline, 30 days, 6, 12 and 24 months ]
    NT ProBNP or BNP creatininemia, ureamia

  15. 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

  16. Cost-effectiveness analysis (economic efficiency) [ Time Frame: 24 months ]
    Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (repair or replacement) Mitral valve area > or = 3 cm2 Minimal calcification in the grasping aera No leaflet cleft in the grasping area Flail width < 15 mm and flail gap < 10 mm
  • Adult patients judged eligible for mitral valve surgery by the local heart team but at high surgical risk defined as:

age > or= 75 years and STS score > or = 6% or one fraily index or major organ system compromise or one possible procedurespecific impediment (using MVARC definitions) or age < 75 years and STS score > 8 % or at least one other high-risk criterion following the MVARC definitions

  • Isolated Mitral valve pathology
  • If revascularization procedures are required, they must be performed more than 30 days from the selection visit
  • 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
  • Any active or recent infection (patient under anti-infectious therapy could not be include) during the last 7 days
  • 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
  • Stroke or transient ischaemic event within 30 days before selection visit
  • Modified Rankin Scale ≥4 disability (appendix 9)
  • TAVR within 30 days before selection visit
  • Untreated, clinically significant coronary artery disease requiring revascularization
  • Any percutaneous cardiovascular intervention within 30 days before selection visit including ATC
  • Cardiovascular surgery, or carotid surgery within 30 days before selection visit
  • Any prior mitral valve surgery or transcatheter mitral valve procedure
  • Need for any concomitant cardiac surgery (including treatment of severe tricuspid regurgitation)
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271762


Contacts
Contact: patrice GUERIN, MD-PHD 0253482887 patrice.guerin@chu-nantes.fr

Locations
France
Chu Angers Not yet recruiting
Angers, France
Contact: FREDERIC PINAUD, MD         
Principal Investigator: THOMAS BENARD, MD         
Principal Investigator: FREDERIC PINAUD, MD         
Chu Bordeaux Not yet recruiting
Bordeaux, France
Contact: LIONEL LEROUX, MD-PHD         
Chru Brest Not yet recruiting
Brest, France
Contact: MARTINE GILARD, MD         
Hopital Henri Mondor Aphp Not yet recruiting
Créteil, France
Contact: EMMANUEL TEIGER         
Chu Grenoble Not yet recruiting
Grenoble, France
Contact: OLIVIER CHAVANON, MD-PHD         
Principal Investigator: OLIVIER CHAVANON, MD-PHD         
Principal Investigator: CAROLE SAUNIER, MD         
Centre Chirurgical Marie Lannelongue Not yet recruiting
Le Plessis-Robinson, France
Contact: SAID GHOSTINE, MD         
CHU LYON Not yet recruiting
Lyon, France
Contact: JEAN-FRANCOIS OBADIA, MD-PHD         
Hopital La Timone Not yet recruiting
Marseille, France
Contact: JEAN-LOUIS BONNET, MD-PHD         
Hopital St Joseph Not yet recruiting
Marseille, France
Contact: REMI HOUEL, MD         
Institut Hospitalier Jacques Cartier Not yet recruiting
Massy, France
Contact: THIERRY LEFEVRE, MD         
Chu Montpellier Not yet recruiting
Montpellier, France
Contact: FREDERIC CRANSAC, MD         
Chu Nantes Not yet recruiting
Nantes, France
Contact: PATRICE GUERIN, MD-PHD         
Sub-Investigator: OUSSAMA AL HABASH, MD         
Sub-Investigator: NICOLAS PIRIOU, MD         
Hopital Bichat Not yet recruiting
Paris, France
Contact: DOMINIQUE HIMBERT, MD         
Hopital Europeen Georges Pompidou Not yet recruiting
Paris, France
Contact: NICOLE KARAM, MD-PHD         
Hopital La Pitie Salpetriere Not yet recruiting
Paris, France
Contact: JEAN-PHILIPPE COLLET         
Institut Mutualiste Montsouris Not yet recruiting
Paris, France
Contact: CHRISTELLE DIAKOV         
Chu Rennes Not yet recruiting
Rennes, France
Contact: GUILLAUME LEURENT         
Centre Cardiologique Du Nord Not yet recruiting
Saint-Denis, France
Contact: MOHAMMED NEJJARI         
Principal Investigator: MOHAMMED NEJJARI         
Principal Investigator: DAVID ATTIAS         
Hopital Civil Strasbourg Not yet recruiting
Strasbourg, France
Contact: PATRICK OHLMANN         
Clinique Pasteur Not yet recruiting
Toulouse, France
Contact: DIDIER TCHETCHE         
Hopital Rangueil Not yet recruiting
Toulouse, France
Contact: THIBAULT LHERMUSIER         
Chru Tours Not yet recruiting
Tours, France
Contact: CHRISTOPHE SAINT ETIENNE         
Sponsors and Collaborators
Nantes University Hospital
Ministère de la Santé
Abbott

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03271762     History of Changes
Other Study ID Numbers: RC17_0002
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:
MITRACLIP
primary Mitral Regurgitation
high surgical risks

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases