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

NCT ID: NCT02371512

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2019-12-31

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.

Conditions

Mitral Valve Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous mitral valve repair (MitraClip system )

Percutaneous mitral valve repair (simultaneous left atrial and ventricular pressure assessment suggested) with MitraClip system (Abbott)

Group Type: EXPERIMENTAL

MitraClip system (Abbott Vascular, Menlo Park, USA)

Intervention Type: DEVICE

Valve repair with the MitraClip system (Abbott Vascular, Menlo Park, USA) consists of a steerable guide through which a Clip Delivery System is advanced to the left atrium.

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)

Group Type: ACTIVE_COMPARATOR

Mitral valve surgery

Intervention Type: PROCEDURE

Mitral valve surgery or mitral valve replacement (technique and access at the discretion of the participating surgical center, MACE procedure and tricuspid annuloplasty possible)

Interventions

MitraClip system (Abbott Vascular, Menlo Park, USA)

Valve repair with the MitraClip system (Abbott Vascular, Menlo Park, USA) consists of a steerable guide through which a Clip Delivery System is advanced to the left atrium.

Intervention Type: DEVICE

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)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Clinical Trials Centre Cologne

OTHER

Sponsor Role: collaborator

Universitätsklinikum Köln

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Baldus, Prof. Dr. med.

Role: STUDY_DIRECTOR

Herzzentrum Uniklinik Köln

Locations

Heart Center University of Cologne

Cologne, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Volker Rudolph, Prof. Dr. med

Role: CONTACT

volker.rudolph@uk-koeln.de

0049 221 47832401

Stephan Baldus, Prof. Dr. med.

Role: CONTACT

stephan.baldus@uk-koeln.de

0049 221 478-32511

Facility Contacts

Volker Rudolph, MD

Role: primary

volker.rudolph@uk-koeln.de

478 32495

References

Baldus S, Doenst T, Pfister R, Gummert J, Kessler M, Boekstegers P, Lubos E, Schroder J, Thiele H, Walther T, Kelm M, Hausleiter J, Eitel I, Fischer-Rasokat U, Bufe A, Schmeisser A, Ince H, Lurz P, von Bardeleben RS, Hagl C, Noack T, Reith S, Beucher H, Reichenspurner H, Rottbauer W, Schulze PC, Muller W, Frank J, Hellmich M, Wahlers T, Rudolph V; MATTERHORN Investigators. Transcatheter Repair versus Mitral-Valve Surgery for Secondary Mitral Regurgitation. N Engl J Med. 2024 Nov 14;391(19):1787-1798. doi: 10.1056/NEJMoa2408739. Epub 2024 Aug 31.

Reference Type: DERIVED

PMID: 39216093 (View on PubMed)

Other Identifiers

MATTERHORN

Identifier Type: -

Identifier Source: org_study_id