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

14. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

246

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Guideline-directed medical therapy (GDMT)
Participants receive GDMT according to current heart failure and valvular heart disease guidelines.
Jiný: 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.
Experimentální: Guideline-directed medical therapy (GDMT) + mitral valve TEER
Participants receive GDMT plus mitral valve TEER
Postup: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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.
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of participants with cardiovascular death
Časové okno: 12 months
Death due to cardiovascular causes during follow-up.
12 months
Number of participants with heart failure hospitalization
Časové okno: 12 months
Hospitalization due to worsening heart failure requiring inpatient treatment.
12 months
Number of participants with myocardial infarction
Časové okno: 12 months
Occurrence of myocardial infarction during follow-up.
12 months
Number of participants with stroke
Časové okno: 12 months
Occurrence of ischemic or hemorrhagic stroke during follow-up.
12 months
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: Baseline, 1, 6, and 12 months
Heart failure biomarkers measured in blood samples.
Baseline, 1, 6, and 12 months

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of participants with all-cause mortality
Časové okno: 12 months
Death from any cause during the study follow-up period.
12 months
Number of participants with procedure-related complications during TEER
Časové okno: 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
Časové okno: 12 months
Emergency or unplanned cardiovascular surgery related to the device or procedure.
12 months
Number of participants with endocarditis
Časové okno: 12 months
Occurrence of infective endocarditis during follow-up.
12 months
Number of participants with major bleeding (TIMI criteria)
Časové okno: 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
Časové okno: 12 months
Occurrence of pericardial tamponade.
12 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Jena University Hospital

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. června 2029

Dokončení studie (Odhadovaný)

1. června 2030

Termíny zápisu do studia

První předloženo

30. června 2026

První předloženo, které splnilo kritéria kontroly kvality

14. července 2026

První zveřejněno (Aktuální)

16. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • ZKSJ0169_MARCER

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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