Clinical trial NCT03271762: Multicentre Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
Official title: Multicentre and Randomized Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Keywords: MITRACLIP
primary Mitral Regurgitation
high surgical risks
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministère de la Santé
name: Abbott
First posted: 2017-09-05
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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
* 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)

Primary outcomes:
measure: All-cause mortality, unplanned hospitalizations for heart failure and mitral valve reintervention
timeFrame: 12 months
Secondary outcomes:
measure: occurrence of a major adverse event
timeFrame: 30 days
Other outcomes:
measure: Overall rate of surgery related Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) Effects (SADEs)
timeFrame: 6, 12 and 24 months
measure: all-cause mortality
timeFrame: 30 days and 6, 12 and 24 months
measure: cardiovascular mortality
timeFrame: 30 days and 6, 12 and 24 months
measure: unplanned heart failure rehospitalization
timeFrame: 6, 12 and 24 months
measure: unplanned rehospitalization rate for cardiovascular reasons
timeFrame: 30 days 6, 12 and 24 months
measure: mitral valve reintervention
timeFrame: 30 days 6, 12 and 24 months
measure: residual MR
timeFrame: 30 days 6, 12 and 24 months
measure: left and right chamber remodelling and parameters (dimension)
timeFrame: baseline, 30 days and 12 months
measure: left and right chamber remodelling and parameters (volume)
timeFrame: baseline, 30 days and 12 months
measure: left ventricular ejection fraction modification
timeFrame: baseline, 30 days and 12 months
measure: mitral valve remodelling
timeFrame: baseline, 30 days and 12 months
measure: Left atrial and pulmonary artery pressures
timeFrame: baseline, 30 days and 12 months
measure: change in 6-minute Walking Test (functional evaluation)
timeFrame: baseline, 6 and 12 months
measure: surveillance of cardiac and renal function
timeFrame: baseline, 30 days, 6, 12 and 24 months
measure: change in Quality of Life scores
timeFrame: baseline, 30 days, 6, 12 and 24 months
measure: Cost-effectiveness analysis (economic efficiency)
timeFrame: 24 months
Locations:
city: Angers
country: France
facility: Chu Angers
city: Annecy
country: France
facility: Ch Annecy
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Bordeaux
country: France
facility: Chu Bordeaux
city: Brest
country: France
facility: Chru Brest
city: Créteil
country: France
facility: Hopital Henri Mondor Aphp
city: Grenoble
country: France
facility: Chu Grenoble
city: Le Plessis-Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
city: Lille
country: France
facility: Chru Lille
city: Lille
country: France
facility: Hopital Prive Le Bois Lille
city: Lyon
country: France
facility: Clinique de La Sauvegarde
city: Lyon
country: France
facility: CHU LYON
city: Marseille
country: France
facility: Hopital Prive Clairval
city: Marseille
country: France
facility: Hopital La Timone
city: Marseille
country: France
facility: Hopital St Joseph
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Montpellier
country: France
facility: Clinique Du Millenaire
city: Nantes
country: France
facility: Chu Nantes
city: Paris
country: France
facility: Hopital Bichat
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital La Pitie Salpetriere
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Poitiers
country: France
facility: Chu Poitiers
city: Rennes
country: France
facility: Chu Rennes
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Denis
country: France
facility: CHU Félix Guyon
city: Saint-Denis
country: France
facility: Centre Cardiologique Du Nord
city: Saint-Étienne
country: France
facility: Chu Saint Etienne
city: Strasbourg
country: France
facility: Hopital Civil Strasbourg
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Hopital Rangueil
city: Tours
country: France
facility: Chru Tours
city: Villeurbanne
country: France
facility: Clinique Du Tonkin
city: Monaco
country: Monaco
facility: Centre Cardio-Thoracique de Monaco
Study officials:
References: