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AzTrials

Mitral Valve InsufficiencyMATTERHORNNCT02371512

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

A study testing MitraClip system (Abbott Vascular, Menlo Park, USA) and Mitral valve surgery in people with Mitral Valve Insufficiency, run by Universitätsklinikum Köln at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mitral Valve Insufficiency
What is being tested?
MitraClip system (Abbott Vascular, Menlo Park, USA) and Mitral valve surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteGermany
Study dates
Feb 2015to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

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

Germany1 site, 1 recruiting

  • Heart Center University of Cologne

    Cologne, 50935

    Volker Rudolph, MD, 478 32495, volker.rudolph@uk-koeln.de

    Recruiting

Other trials in Germany

About this study

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

Read the 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.

Being tested
MitraClip system (Abbott Vascular, Menlo Park, USA), Mitral valve surgery
Keywords
Mitral Valve Insufficiency
Medical subject headings
Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Mitral valve surgeryProcedure or 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)

Study groups in NCT02371512
Study groupRoleWhat they receive
Percutaneous mitral valve repair (MitraClip system )ExperimentalPercutaneous mitral valve repair (simultaneous left atrial and ventricular pressure assessment suggested) with MitraClip system (Abbott)
Receives: Device: MitraClip system (Abbott Vascular, Menlo Park, USA)
Mitral valve surgeryActive comparatorMitral valve surgery or mitral valve replacement (technique and access at the discretion of the participating surgical center, MACE procedure and tricuspid annuloplasty possible)
Receives: Procedure: Mitral valve surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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"

    Measured: 12 months post intervention

Secondary outcomes (8)

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

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

    Measured: 12 months post intervention

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

    Change in 6 Minute Walk Test distance from baseline to 12 month post intervention (difference "12 months minus baseline

    Measured: 12 months post intervention

  3. Change in NYHA functional class from baseline to 12 months post intervention

    Change in NYHA functional class from baseline to 12 months post intervention

    Measured: 12 months post intervention

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

    Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline to 12 months post intervention

    Measured: 12 months post intervention

  5. Echocardiographic assessment of left ventricular remodelling

    Measured: 12 months post intervention

  6. Change in serum BNP from baseline to 12 months post intervention

    Measured: 12 months post intervention

  7. Length of stay ICU / hospital

    Measured: 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)

    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.

    Measured: 12 months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02371512
Sponsor's protocol ID
MATTERHORN
Acronym
MATTERHORN
Status last verified
Jul 2017
First submitted
18 Feb 2015
Last updated
1 Aug 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 39216093

Questions about this trial

What is this clinical trial studying?

A study testing MitraClip system (Abbott Vascular, Menlo Park, USA) and Mitral valve surgery in people with Mitral Valve Insufficiency, run by Universitätsklinikum Köln at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Volker Rudolph, Prof. Dr. med (0049 221 47832401, volker.rudolph@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02371512, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.

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