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

Mitral Regurgitation Clinical Trial

— MITRA-HR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03271762
• Other study ID #: RC17_0002
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2018
• Est. completion date: May 2027

Study information

• Verified date: January 2024
• Source: Nantes University Hospital
• Contact: PATRICE GUERIN, MD-PHD
• Phone: 02.40.16.55.92
• Email: patrice.guerin[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: May 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

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

Procedure:
• cardiac surgery
mitral valve repair or mitral valve remplacement

Locations

Country	Name	City	State
France	Chu Angers	Angers
France	Ch Annecy	Annecy
France	Chu Bordeaux	Bordeaux
France	Clinique Saint Augustin	Bordeaux
France	Chru Brest	Brest
France	Hopital Henri Mondor Aphp	Créteil
France	Chu Grenoble	Grenoble
France	Centre Chirurgical Marie Lannelongue	Le Plessis-Robinson
France	Chru Lille	Lille
France	Hopital Prive Le Bois Lille	Lille
France	CHU LYON	Lyon
France	Clinique de La Sauvegarde	Lyon
France	Hopital La Timone	Marseille
France	Hopital Prive Clairval	Marseille
France	Hopital St Joseph	Marseille
France	Institut Hospitalier Jacques Cartier	Massy
France	Clinique Du Millenaire	Montpellier
France	Chu Nantes	Nantes
France	Hopital Bichat	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	Hopital La Pitie Salpetriere	Paris
France	Institut Mutualiste Montsouris	Paris
France	Chu Poitiers	Poitiers
France	Chu Rennes	Rennes
France	CHU de Rouen	Rouen
France	Centre Cardiologique Du Nord	Saint-Denis
France	Chu Saint Etienne	Saint-Étienne
France	Hopital Civil Strasbourg	Strasbourg
France	Clinique Pasteur	Toulouse
France	Hopital Rangueil	Toulouse
France	Chru Tours	Tours
France	Clinique Du Tonkin	Villeurbanne
Monaco	Centre Cardio-Thoracique de Monaco	Monaco

Sponsors (3)

Lead Sponsor	Collaborator
Nantes University Hospital	Abbott, Ministère de la Santé

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall rate of surgery related Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) Effects (SADEs)	SAEs et SADEs rate related to protocol procedure all SAEs and SADEs	6, 12 and 24 months
Other	all-cause mortality	Rate of global mortality (all-causes)	30 days and 6, 12 and 24 months
Other	cardiovascular mortality	Rate of cardiovascular mortality	30 days and 6, 12 and 24 months
Other	unplanned heart failure rehospitalization	Rate of unplanned heart failure rehospitalization	6, 12 and 24 months
Other	unplanned rehospitalization rate for cardiovascular reasons	Rate of unplanned rehospitalization for cardiovascular reasons	30 days 6, 12 and 24 months
Other	mitral valve reintervention	Mitral valve reintervention rate	30 days 6, 12 and 24 months
Other	residual MR	MR (Mitral Regurgitation): grade	30 days 6, 12 and 24 months
Other	left and right chamber remodelling and parameters (dimension)	End-systolic dimension End-diastolic dimension Left atrial dimension	baseline, 30 days and 12 months
Other	left and right chamber remodelling and parameters (volume)	End-systolic volume End-diastolic volume Left atrial volume	baseline, 30 days and 12 months
Other	left ventricular ejection fraction modification	Left ventricular ejection fraction	baseline, 30 days and 12 months
Other	mitral valve remodelling	Mitral valve area and mean gradient	baseline, 30 days and 12 months
Other	Left atrial and pulmonary artery pressures	Left atrial and pulmonary artery pressures	baseline, 30 days and 12 months
Other	change in 6-minute Walking Test (functional evaluation)	6-minute Walking Test	baseline, 6 and 12 months
Other	surveillance of cardiac and renal function	NT ProBNP or BNP creatininemia, ureamia	baseline, 30 days, 6, 12 and 24 months
Other	change in Quality of Life scores	Quality of Life EQ-5D score SF-36 score	baseline, 30 days, 6, 12 and 24 months
Other	Cost-effectiveness analysis (economic efficiency)	Incremental cost-effectiveness ratio (cost per Quality-Adjusted Life-Year, QALY)	24 months
Primary	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	12 months
Secondary	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	30 days