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Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation (MARCER)

14. Juli 2026 aktualisiert von: Christian Schulze, Jena University Hospital

Mitral Valve Edge-to-Edge Reconstruction in Patients With Exercise-Induced Severe Secondary Mitral Regurgitation and Heart Failure

The goal of this clinical trial is to learn whether mitral valve transcatheter edge-to-edge repair (TEER) in addition to guideline-directed medical therapy (GDMT) can improve clinical outcomes and symptoms in heart failure patients with non-severe secondary mitral regurgitation (SMR) at rest and exercise-induced severe SMR.

The main questions it aims to answer are:

  • Does mitral valve TEER in addition to GDMT lead to better overall clinical outcomes than GDMT alone in patients with heart failure and exercise-induced severe SMR?
  • Does mitral valve TEER reduce the risk of death, heart failure hospitalization, or worsening SMR during 12 months of follow-up compared with GDMT alone?
  • Does mitral valve TEER improve patients' quality of life compared with GDMT alone?

Participants will:

  • Undergo screening assessments to confirm eligibility for the study.
  • Be randomly assigned to receive either GDMT alone or GDMT plus mitral valve TEER.
  • Attend follow-up visits at approximately 3 time points during a 12-month follow-up period.
  • Undergo clinical evaluations that are routinely performed in patients with heart failure and SMR, including assessment of symptoms, functional status, and cardiac function.

The patients' echocardiographic data will undergo an additional centralized assessment by an independent Core Laboratory.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

246

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Deutschland
      • Düsseldorf, Deutschland
        • Department of Cardiology, Pneumology and Vascular Medicine University Hospital Düsseldorf
        • Kontakt:
        • Hauptermittler:
          • Maximilian Spieker, PD Dr.
      • Jena, Deutschland
        • Department of Internal Medicine I (KIM I) Division of Cardiology, Angiology and Intensive Medical Care Jena University Hospital
        • Kontakt:
        • Hauptermittler:
          • Christian Schulze, Prof. Dr.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Mild-to-moderate (1+/2+) SMR at rest

  • Exacerbation of SMR to exercise-induced severe (3+/4+) SMR defined by at least one of the following:

    • 40 mm^2 EROA (30 mm^2 under low-flow condition) or
    • regurgitant volume ≥60 mL (45 mL under low-flow condition) or
    • regurgitant fraction ≥40% or
    • increase by 13 mm^2 EROA from rest to exercise

  • Increase in natriuretic peptides defined as NT-proBNP:

    • >250 pg/ml (Sinus rhythm) or
    • >600 pg/ml (Atrial fibrillation) or
    • HF hospitalization within 12 months prior to screening (defined as HF listed as the major reason for hospitalization)
  • NYHA class II-IV
  • Stable HF medication regimen (GDMT) for at least 30 days prior to index procedure
  • Patient deemed appropriate candidate for TEER by the local multidisciplinary heart team
  • Age ≥ 18 years old
  • Written Informed consent

Exclusion Criteria:

  • Hospitalization in past three months due to myocardial infarction, coronary artery bypass graft surgery, and/or unstable angina
  • LVEDD >70 mm
  • LVEF <20%
  • Evidence of transient ischemic attack or stroke within three months prior to intervention
  • Percutaneous coronary intervention in the last 30 days
  • Subjects expected to require any cardiac surgery, including surgery for coronary artery disease or for pulmonic, aortic, or tricuspid valve disease within one year
  • Presence of primary renal dysfunction or significantly compromised renal function (eGFR <30 ml/min)
  • Severe right ventricular failure
  • Severe aortic stenosis (aortic valve area <1.0 cm^2) or aortic regurgitation
  • Hemodynamic instability requiring inotropic support or mechanical heart circulatory support
  • Presence of a mechanical mitral heart valve, mitral bioprosthetic valve or mitral annuloplasty ring, indication for cardiac resynchronization therapy
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  • Active endocarditis or infections requiring current antibiotic therapy
  • Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing HF other than SMR
  • Inability to exercise
  • Pregnancy or planning pregnancy within next12 months
  • Life expectancy <12 months (judgement of investigator)
  • Anticipated need of left ventricular assist device within next 12 months
  • Participation in another interventional clinical trial (primary endpoint not yet reached) during this trial or within 30 days prior to enrolment into this trial
  • Previous participation in this trial

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Guideline-directed medical therapy (GDMT)
Participants receive GDMT according to current heart failure and valvular heart disease guidelines.
Sonstiges: Guideline-Directed Medical Therapy (GDMT)
Participants receive guideline-directed medical therapy (GDMT) for heart failure and secondary mitral regurgitation (SMR) according to current clinical practice guidelines. Medical treatment may include optimized pharmacological therapy such as beta-blockers, ACE inhibitors/ARBs/ARNI, mineralocorticoid receptor antagonists, diuretics, SGLT2-inhibitors and other indicated medications. Treatment is adjusted based on clinical status and treating physician judgment.
Experimental: Guideline-directed medical therapy (GDMT) + mitral valve TEER
Participants receive GDMT plus mitral valve TEER
Verfahren: Mitral valve TEER
Participants receive guideline-directed medical therapy (GDMT) for heart failure and secondary mitral regurgitation (SMR) according to current clinical practice guidelines in combination with TEER of the mitral valve using the PASCAL Precision system (Edwards Lifesciences Sàrl). The procedure is performed via a minimally invasive transcatheter approach through femoral venous access to reduce SMR. Guideline-directed medical therapy is continued and optimized throughout follow-up according to standard of care.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Four-step hierarchical composite primary endpoint; win ratio based on the following parameters: time to all-cause mortality at 12 months, time to first HF hospitalization, SMR progression (3+/4+) at rest, change in KCCQ score from baseline to 12 months.
Zeitfenster: 12 months

The primary outcome is a single aggregated, unitless win ratio based on a four-step hierarchical composite primary endpoint at 12 months. Each patient in the GDMT+mitral valve TEER group will be compared with each patient in the GDMT group with respect to the following parameters in the following order:

  1. time to all-cause mortality, days
  2. time to first heart failure hospitalization, days
  3. secondary mitral regurgitation progression (3+/4+) at rest and
  4. change in KCCQ score from baseline to 12 months, where higher improvement or less deterioration wins; differences between patients less than 5 points are treated as ties (i.e. a between-patient threshold of 5 pts., KCCQ-values range from 0 to 100, higher values indicating better health).

For each pairwise comparison, the first non-tied component determines a win for one group or a tie. The win ratio is the number of wins in the GDMT+ mitral valve TEER group divided by the number of wins in the GDMT group.
12 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants with cardiovascular death
Zeitfenster: 12 months
Death due to cardiovascular causes during follow-up.
12 months
Number of participants with heart failure hospitalization
Zeitfenster: 12 months
Hospitalization due to worsening heart failure requiring inpatient treatment.
12 months
Number of participants with myocardial infarction
Zeitfenster: 12 months
Occurrence of myocardial infarction during follow-up.
12 months
Number of participants with stroke
Zeitfenster: 12 months
Occurrence of ischemic or hemorrhagic stroke during follow-up.
12 months
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Zeitfenster: Baseline, 1, 6, and 12 months
Health-related quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ): scores range from 0 to 100, with higher scores indicating better health status.
Baseline, 1, 6, and 12 months
Change from baseline in 36-Item Short Form Survey (SF-36) score
Zeitfenster: Baseline, 1, 6, and 12 months
General health-related quality of life assessed using the SF-36 questionnaire, including physical and mental component summary scores.
Baseline, 1, 6, and 12 months
Number of participants requiring mitral valve surgery
Zeitfenster: 12 months
Occurrence of surgical mitral valve intervention during follow-up.
12 months
Change from baseline in secondary mitral regurgitation severity grade according to the American Society of Echocardiography (ASE) criteria at rest
Zeitfenster: Baseline, 1, 6, and 12 months
Secondary mitral regurgitation severity will be assessed at rest by transthoracic echocardiography according to the American Society of Echocardiography (ASE) criteria using a 4-grade scale: Grade 1 (mild), Grade 2 (moderate), Grade 3 (moderate-to-severe), and Grade 4 (severe). Severity grading will be based on an integrated assessment of echocardiographic parameters, including effective regurgitant orifice area (EROA), regurgitant volume (RVol), and regurgitant fraction (RF).
Baseline, 1, 6, and 12 months
Change from baseline in left ventricular end-systolic volume index (LVESVi)
Zeitfenster: Baseline, 1, 6, and 12 months
Left ventricular end-systolic volume index measured by echocardiography.
Baseline, 1, 6, and 12 months
Change from baseline in left ventricular end-diastolic volume index (LVEDVi)
Zeitfenster: Baseline, 1, 6, and 12 months
Left ventricular end-diastolic volume index measured by echocardiography.
Baseline, 1, 6, and 12 months
Change from baseline in pulmonary artery systolic pressure (SPAP)
Zeitfenster: Baseline, 1, 6, and 12 months
Pulmonary artery systolic pressure assessed by echocardiography.
Baseline, 1, 6, and 12 months
Change from baseline in New York Heart Association (NYHA) functional class
Zeitfenster: Baseline, 1, 6, and 12 months
Heart failure functional status assessed using NYHA classification.
Baseline, 1, 6, and 12 months
Change from baseline in six-minute walk test (6MWT) distance
Zeitfenster: Baseline, 1, 6, and 12 months
Exercise capacity assessed using the six-minute walk test.
Baseline, 1, 6, and 12 months
Change from baseline in NT-proBNP (N-terminal pro Brain natriuretic peptide, pg/ml) (alternatively calculated from BNP, Brain natriuretic peptide, pg/ml)
Zeitfenster: Baseline, 1, 6, and 12 months
Heart failure biomarkers measured in blood samples.
Baseline, 1, 6, and 12 months

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants with all-cause mortality
Zeitfenster: 12 months
Death from any cause during the study follow-up period.
12 months
Number of participants with procedure-related complications during TEER
Zeitfenster: During procedure
Complications occurring during or immediately after the TEER procedure.
During procedure
Number of participants requiring non-elective cardiovascular surgery for device-related complications
Zeitfenster: 12 months
Emergency or unplanned cardiovascular surgery related to the device or procedure.
12 months
Number of participants with endocarditis
Zeitfenster: 12 months
Occurrence of infective endocarditis during follow-up.
12 months
Number of participants with major bleeding (TIMI criteria)
Zeitfenster: 12 months
Major bleeding events defined according to the Thrombolysis In Myocardial Infarction (TIMI) bleeding criteria, including fatal bleeding, intracranial hemorrhage, or clinically significant bleeding associated with a drop in hemoglobin ≥5 g/dL or hematocrit ≥15%.
12 months
Number of participants with cardiac tamponade
Zeitfenster: 12 months
Occurrence of pericardial tamponade.
12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Jena University Hospital

Ermittler

  • Studienleiter: Christian Schulze, Prof. Dr., University Hospital Jena
  • Studienleiter: Maximilian Spieker, PD Dr., Heinrich-Heine University, Duesseldorf

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Juni 2029

Studienabschluss (Geschätzt)

1. Juni 2030

Studienanmeldedaten

Zuerst eingereicht

30. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Juli 2026

Zuerst gepostet (Tatsächlich)

16. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • ZKSJ0169_MARCER

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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