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Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation (DMR)

18 mai 2026 mis à jour par: Aakriti Gupta, Cedars-Sinai Medical Center

Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation: A Comparative Study of Clinical Outcomes, Patient Experiences, and Mechanistic Insights With Multimodality Imaging

The goal of this observational study is to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term. The study aims to:

  1. Evaluate the effectiveness and safety of TEER versus surgery in patients with DMR over long term.
  2. Investigate the predictors of left ventricular dysfunction and clinical outcomes using advanced imaging techniques, such as cardiac MRI
  3. Assess patient-reported recovery and quality of life outcomes using validated tools.

The study focuses on improving care strategies for patients with DMR, particularly those at higher surgical risk, by identifying optimal treatment approaches and predictors of recovery.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

This is an ambispective, (prospective and retrospective) cohort study collecting clinical, procedural, and follow-up data to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term.

Type d'étude

Observationnel

Inscription (Estimé)

60

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • California
      • Los Angeles, California, États-Unis, 90048
        • Recrutement
        • Smidt Heart Institute, Cedars Sinai Medical Center
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The study population includes adult patients with severe degenerative mitral regurgitation (DMR) who underwent either surgical mitral valve repair or transcatheter edge-to-edge repair (TEER).

La description

Inclusion Criteria:

  • Patients older than 60 years who have DMR will be included in the study

Exclusion Criteria:

  • Patients with prior history of mitral intervention or surgery will be excluded.
  • Patient records flagged "break the glass" or "research opt out" will be excluded.
  • Persons with allergy to animal dander or animal-instigated asthma will be excluded.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Surgical mitral repair
This cohort includes patients who underwent surgical mitral valve repair for severe degenerative mitral regurgitation (DMR). The intervention involves standard surgical techniques to repair the mitral valve, aiming to restore its physiological function and reduce mitral regurgitation.
Transcatheter mitral edge-to-edge repair
This cohort includes patients who underwent transcatheter edge-to-edge repair (TEER) for severe degenerative mitral regurgitation (DMR). The intervention involves a minimally invasive transcatheter procedure using a device to approximate the mitral valve leaflets, reducing regurgitation.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
Délai: From procedure to 3 years after procedure
Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
From procedure to 3 years after procedure

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography
Délai: At 30 days, 6 months, and 1 year after procedure
Percentage of participants with residual mitral regurgitation greater than 2+ assessed by transthoracic echocardiography after surgical mitral valve repair or transcatheter edge-to-edge repair.
At 30 days, 6 months, and 1 year after procedure
Left Ventricular Ejection Fraction by Transthoracic Echocardiography
Délai: At 30 days, 6 months, and 1 year after procedure
Left ventricular ejection fraction, measured as percentage by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.
At 30 days, 6 months, and 1 year after procedure
Mean Mitral Valve Gradient by Transthoracic Echocardiography
Délai: At 30 days, 6 months, and 1 year after procedure
Mean transmitral valve gradient, measured in mm Hg by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.
At 30 days, 6 months, and 1 year after procedure
Kansas City Cardiomyopathy Questionnaire Overall Summary Score
Délai: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
Kansas City Cardiomyopathy Questionnaire overall summary score, measured on a 0 to 100 scale, will be used to assess patient-reported health status after surgical mitral valve repair or transcatheter edge-to-edge repair. Higher scores indicate better health status.
At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
Six-Minute Walk Test Distance
Délai: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
Functional capacity will be assessed using the 6-minute walk test distance, measured in meters.
At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
SF-36 Physical Component Summary Score
Délai: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
The SF-36 Physical Component Summary score will be used to assess patient-reported physical health status. Scores are reported as scale scores, with higher scores indicating better physical health status.
At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
SF-36 Mental Component Summary Score
Délai: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
The SF-36 Mental Component Summary score will be used to assess patient-reported mental health status. Higher scores indicate better mental health status.
At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
Percentage of Participants With All-Cause Mortality
Délai: At 30 days, 6 months, 1 year, and 5 years after procedure
Percentage of participants with all-cause mortality after surgical mitral valve repair or transcatheter edge-to-edge repair.
At 30 days, 6 months, 1 year, and 5 years after procedure
Percentage of Participants With Heart Failure Hospitalization
Délai: At 30 days, 6 months, 1 year, and 5 years after procedure
Percentage of participants hospitalized for heart failure after surgical mitral valve repair or transcatheter edge-to-edge repair.
At 30 days, 6 months, 1 year, and 5 years after procedure
Mitral Valve Reintervention
Délai: At 30 days, 6 months, 1 year, and 5 years after procedure
Percentage of participants requiring mitral valve reintervention after surgical mitral valve repair or transcatheter edge-to-edge repair.
At 30 days, 6 months, 1 year, and 5 years after procedure

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With One or More Major Periprocedural or 30-Day Complications
Délai: From start of procedure to 30 days after procedure
Percentage of participants with one or more major periprocedural or 30-day complications after surgical mitral valve repair or transcatheter edge-to-edge repair. Major complications include coronary obstruction, cardiac tamponade, new left bundle branch block, major bleeding, stroke or transient ischemic attack, myocardial infarction, acute kidney injury, new-onset atrial fibrillation, infection or sepsis, permanent pacemaker implantation, or conversion to open surgery.
From start of procedure to 30 days after procedure
Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular Ejection Fraction
Délai: From baseline CMR to 6 months after procedure
Correlation between baseline myocardial extracellular volume, measured as percentage extracellular volume by cardiovascular magnetic resonance imaging, and left ventricular ejection fraction, measured as percentage by transthoracic echocardiography at 6 months after procedure.
From baseline CMR to 6 months after procedure
Difference in 6-Month Left Ventricular Ejection Fraction by Baseline Late Gadolinium Enhancement Presence
Délai: From baseline CMR to 6 months after procedure
Difference in 6-month left ventricular ejection fraction, measured as percentage by transthoracic echocardiography, between participants with and without baseline late gadolinium enhancement on cardiovascular magnetic resonance imaging.
From baseline CMR to 6 months after procedure
Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular End-Systolic Volume Index
Délai: From baseline CMR to 6 months after procedure
Correlation between baseline myocardial extracellular volume, measured as percentage extracellular volume by cardiovascular magnetic resonance imaging, and left ventricular end-systolic volume index, measured in mL/m² by cardiovascular magnetic resonance imaging at 6 months after procedure.
From baseline CMR to 6 months after procedure

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Cedars-Sinai Medical Center

Collaborateurs

National Heart, Lung, and Blood Institute (NHLBI)

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 février 2025

Achèvement primaire (Estimé)

1 août 2027

Achèvement de l'étude (Estimé)

1 août 2027

Dates d'inscription aux études

Première soumission

16 mars 2026

Première soumission répondant aux critères de contrôle qualité

18 mai 2026

Première publication (Réel)

26 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • STUDY00003584
  • 1R56HL175516-01 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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