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

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ClinicalTrials.gov Identifier: NCT02371512
Recruitment Status : Recruiting
First Posted : February 25, 2015
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
The Clinical Trials Centre Cologne
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Device: MitraClip system (Abbott Vascular, Menlo Park, USA) Procedure: Mitral valve surgery Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Controlled Study to Assess Mitral vAlve reconsTrucTion for advancEd Insufficiency of Functional or iscHemic ORigiN
Study Start Date : February 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Percutaneous mitral valve repair (MitraClip system )
Percutaneous mitral valve repair (simultaneous left atrial and ventricular pressure assessment suggested) with MitraClip system (Abbott)
Device: 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.

Active Comparator: 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)
Procedure: 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 :
  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" [ Time Frame: 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 :
  1. Recurrence of grade 3 or 4 mitral regurgitation within 12 months post intervention [ Time Frame: 12 months post intervention ]
    Recurrence of grade 3 or 4 mitral regurgitation within 12 months post intervention

  2. Change in 6 Minute Walk Test distance from baseline to 12 month post intervention (difference "12 months minus baseline [ Time Frame: 12 months post intervention ]
    Change in 6 Minute Walk Test distance from baseline to 12 month post intervention (difference "12 months minus baseline

  3. Change in NYHA functional class from baseline to 12 months post intervention [ Time Frame: 12 months post intervention ]
    Change in NYHA functional class from baseline to 12 months post intervention

  4. Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline to 12 months post intervention [ Time Frame: 12 months post intervention ]
    Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline to 12 months post intervention

  5. Echocardiographic assessment of left ventricular remodelling [ Time Frame: 12 months post intervention ]
  6. Change in serum BNP from baseline to 12 months post intervention [ Time Frame: 12 months post intervention ]
  7. Length of stay ICU / hospital [ Time Frame: 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. ]
  8. Number of patients in whom operative or interventional mitral valve repair can not be performed (need for mitral valve replacement) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371512


Contacts
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Contact: Volker Rudolph, Prof. Dr. med 0049 221 47832401 volker.rudolph@uk-koeln.de
Contact: Stephan Baldus, Prof. Dr. med. 0049 221 478-32511 stephan.baldus@uk-koeln.de

Locations
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Germany
Heart Center University of Cologne Recruiting
Cologne, Germany, 50935
Contact: Volker Rudolph, MD    478 32495    volker.rudolph@uk-koeln.de   
Sponsors and Collaborators
Universitätsklinikum Köln
The Clinical Trials Centre Cologne
Investigators
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Study Director: Stephan Baldus, Prof. Dr. med. Herzzentrum Uniklinik Köln

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Responsible Party: Universitätsklinikum Köln
ClinicalTrials.gov Identifier: NCT02371512     History of Changes
Other Study ID Numbers: MATTERHORN
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Keywords provided by Universitätsklinikum Köln:
Mitral Valve Insufficiency
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases