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

14 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

246

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Guideline-directed medical therapy (GDMT)
Participants receive GDMT according to current heart failure and valvular heart disease guidelines.
Altro: 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.
Sperimentale: Guideline-directed medical therapy (GDMT) + mitral valve TEER
Participants receive GDMT plus mitral valve TEER
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 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

Misure di risultato secondarie

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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of participants with all-cause mortality
Lasso di tempo: 12 months
Death from any cause during the study follow-up period.
12 months
Number of participants with procedure-related complications during TEER
Lasso di tempo: 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
Lasso di tempo: 12 months
Emergency or unplanned cardiovascular surgery related to the device or procedure.
12 months
Number of participants with endocarditis
Lasso di tempo: 12 months
Occurrence of infective endocarditis during follow-up.
12 months
Number of participants with major bleeding (TIMI criteria)
Lasso di tempo: 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
Lasso di tempo: 12 months
Occurrence of pericardial tamponade.
12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Jena University Hospital

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 giugno 2029

Completamento dello studio (Stimato)

1 giugno 2030

Date di iscrizione allo studio

Primo inviato

30 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 luglio 2026

Primo Inserito (Effettivo)

16 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • ZKSJ0169_MARCER

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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