A Multicenter, Randomized, Controlled Study to Assess Mitral vAlve reconsTrucTion for advancEd Insufficiency of Functional or iscHemic ORigiN

Not Applicable

• Conditions: Mitral Valve Insufficiency
• Interventions: Device: MitraClip system (Abbott Vascular, Menlo Park, USA); Procedure: Mitral valve surgery

• Registration Number: NCT02371512
• Lead Sponsor: Universitätsklinikum Köln

Brief Summary

Study to assess mitral valve therapy for advanced insufficiency of functional or ischemic origin in patients with moderate-to-severe mitral regurgitation (MR) of primarily functional pathology and reduced left ventricular function considered to be at high surgical risk

Detailed Description

Secondary or functional mitral regurgitation (MR) results from a geometrical distortion of a dysfunctional left ventricle leading to tethering of mitral valve leaflets by papillary muscle displacement, annular dilatation and/or reduced closing forces in a structurally normal mitral valve. It occurs in over 30% of patients with systolic heart failure. Despite optimal medical care it is associated with increased mortality and hospitalization rates leaving elimination of MR as the only therapeutic option. Nevertheless, traditionally, mitral valve surgery has been the therapy of choice in this setting.

As mitral valve surgery has so far been only investigated in retrospective single center registries, which have shown conflicting results. it has a class IIb recommendation, level of evidence C, in these patients without indication for coronary revascularization in the current guidelines of the European Society of Cardiology. In recent years percutaneous mitral valve repair with the MitraClip (PMVR) has evolved as an important therapeutic option in this type of patient with widespread use particularly in Europe, where the device was CE-marked in 2008. PMVR has been compared to mitral valve surgery (repair and replacement) in the randomized, controlled EVEREST II trial in patients with primary MR, which were good candidates for surgery, and was shown to be less effective than surgery in this context. However, no randomized, controlled data are available comparing PMVR and mitral valve surgery in patients with depressed left ventricular function and secondary MR, who have a considerably higher perioperative risk than the EVEREST II population. Like mitral valve surgery it has a class IIb, level of evidence C, recommendation in current guidelines.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-18
• Study First Submitted QC: 2015-02-19
• Study First Posted: 2015-02-25
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-01
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Clinically significant mitral regurgitation of primarily functional pathology
• Left Ventricular Ejection Fraction (LVEF) ≥20% determined by echocardiography
• High surgical risk as determined by Heart Team consensus
• Documented New York Heart Association Class II to Class IV heart failure, despite optimal standard of care therapy
• Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria

• Echocardiographic evaluation not available or not suitable for analysis at baseline
• Severe tricuspid regurgitation according to current guidelines5
• Other severe valve disorders requiring intervention according to current
• Coronary revascularization or cardiac resynchronization (CRT) device implantation within 1 month before the procedure
• Patient not amenable for mitral valve surgery/ percutaneous mitral valve reconstruction as judged by Heart Team
• Key information from patients (e.g. NYHA, MR grade) not available

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous mitral valve repair (MitraClip system )	MitraClip system (Abbott Vascular, Menlo Park, USA)	Percutaneous mitral valve repair (simultaneous left atrial and ventricular pressure assessment suggested) with MitraClip system (Abbott)
Mitral valve surgery	Mitral valve surgery	Mitral valve surgery or mitral valve replacement (technique and access at the discretion of the participating surgical center, MACE procedure and tricuspid annuloplasty possible)

Primary Outcome Measures

Name	Time	Method
Composite of death, rehospitalisation for heart failure, reintervention (repeat operation or repeat intervention), assist device implantation and stroke (whatever is first) 12 months post intervention; equivalently "freedom from event"	12 months post intervention	Composite of death, rehospitalisation for heart failure, reintervention (repeat operation or repeat intervention), assist device implantation and stroke (whatever is first) 12 months post intervention; equivalently "freedom from event"

Secondary Outcome Measures

Name	Time	Method
Change in 6 Minute Walk Test distance from baseline to 12 month post intervention (difference "12 months minus baseline	12 months post intervention	Change in 6 Minute Walk Test distance from baseline to 12 month post intervention (difference "12 months minus baseline
Change in NYHA functional class from baseline to 12 months post intervention	12 months post intervention	Change in NYHA functional class from baseline to 12 months post intervention
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline to 12 months post intervention	12 months post intervention	Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline to 12 months post intervention
Echocardiographic assessment of left ventricular remodelling	12 months post intervention
Change in serum BNP from baseline to 12 months post intervention	12 months post intervention
Length of stay ICU / hospital	Participants will be followed for the duration of hospital stay, an expected average of 1 week. However, in some patients the hospital stay can be exceed this time frame, when complications occur.
Number of patients in whom operative or interventional mitral valve repair can not be performed (need for mitral valve replacement)	12 months post intervention	The primary therapeutic strategy should be a repair of the study. For patients undergoing interventional therapy this endpoint is reached if the clip procedure is aborted and a mitral valve replacement is performed. In patients undergoing surgery the endpoint is reached if the surgeon decides to implant a mitral valve during the same procedure.
Recurrence of grade 3 or 4 mitral regurgitation within 12 months post intervention	12 months post intervention	Recurrence of grade 3 or 4 mitral regurgitation within 12 months post intervention

Trial Locations

Locations (1)

Heart Center University of Cologne; 🇩🇪 Cologne, Germany