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

NCT02371512 | Unknown DMC

• 1 other identifier: MATTERHORN
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Conditions

Mitral Valve Insufficiency

Keywords

Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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"

  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

Secondary Outcomes (8)

• Recurrence of grade 3 or 4 mitral regurgitation within 12 months post intervention

  12 months post intervention

• 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 NYHA functional class 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

  12 months post intervention

• Echocardiographic assessment of left ventricular remodelling

  12 months post intervention

Study Arms (2)

Percutaneous mitral valve repair (MitraClip system )

EXPERIMENTAL

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

Device: MitraClip system (Abbott Vascular, Menlo Park, USA)

Mitral valve surgery

ACTIVE COMPARATOR

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

Procedure: Mitral valve surgery

Interventions

MitraClip system (Abbott Vascular, Menlo Park, USA) 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.

Percutaneous mitral valve repair (MitraClip system )

Mitral valve surgery 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)

Mitral valve surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Köln: lead
• The Clinical Trials Centre Cologne: collaborator

Study Sites (1)

Heart Center University of Cologne

Cologne, 50935, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 39216093 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Stephan Baldus, Prof. Dr. med.

  Herzzentrum Uniklinik Köln

  STUDY DIRECTOR

Central Study Contacts

Volker Rudolph, Prof. Dr. med

CONTACT

0049 221 47832401; volker.rudolph@uk-koeln.de

Stephan Baldus, Prof. Dr. med.

CONTACT

0049 221 478-32511; stephan.baldus@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: February 25, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

DE (1)