Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation (DMR)
18 de mayo de 2026 actualizado por: 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:
- Evaluate the effectiveness and safety of TEER versus surgery in patients with DMR over long term.
- Investigate the predictors of left ventricular dysfunction and clinical outcomes using advanced imaging techniques, such as cardiac MRI
- 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
60
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Aakriti Gupta, M.D.
- Número de teléfono: 267-442-8776
- Correo electrónico: aakriti.gupta@cshs.org
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90048
- Reclutamiento
- Smidt Heart Institute, Cedars Sinai Medical Center
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Contacto:
- Aakriti Gupta, M.D.
- Número de teléfono: 267-442-8776
- Correo electrónico: aakriti.gupta@cshs.org
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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).
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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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.
|
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
Periodo de tiempo: From procedure to 3 years after procedure
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Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
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From procedure to 3 years after procedure
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography
Periodo de tiempo: 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.
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At 30 days, 6 months, and 1 year after procedure
|
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Left Ventricular Ejection Fraction by Transthoracic Echocardiography
Periodo de tiempo: At 30 days, 6 months, and 1 year after procedure
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Left ventricular ejection fraction, measured as percentage by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, and 1 year after procedure
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Mean Mitral Valve Gradient by Transthoracic Echocardiography
Periodo de tiempo: At 30 days, 6 months, and 1 year after procedure
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Mean transmitral valve gradient, measured in mm Hg by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, and 1 year after procedure
|
|
Kansas City Cardiomyopathy Questionnaire Overall Summary Score
Periodo de tiempo: 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.
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At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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Six-Minute Walk Test Distance
Periodo de tiempo: 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.
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At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
|
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SF-36 Physical Component Summary Score
Periodo de tiempo: 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.
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At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
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SF-36 Mental Component Summary Score
Periodo de tiempo: 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.
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At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
|
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Percentage of Participants With All-Cause Mortality
Periodo de tiempo: At 30 days, 6 months, 1 year, and 5 years after procedure
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Percentage of participants with all-cause mortality after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, 1 year, and 5 years after procedure
|
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Percentage of Participants With Heart Failure Hospitalization
Periodo de tiempo: At 30 days, 6 months, 1 year, and 5 years after procedure
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Percentage of participants hospitalized for heart failure after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, 1 year, and 5 years after procedure
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Mitral Valve Reintervention
Periodo de tiempo: At 30 days, 6 months, 1 year, and 5 years after procedure
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Percentage of participants requiring mitral valve reintervention after surgical mitral valve repair or transcatheter edge-to-edge repair.
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At 30 days, 6 months, 1 year, and 5 years after procedure
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants With One or More Major Periprocedural or 30-Day Complications
Periodo de tiempo: From start of procedure to 30 days after procedure
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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.
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From start of procedure to 30 days after procedure
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Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular Ejection Fraction
Periodo de tiempo: From baseline CMR to 6 months after procedure
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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.
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From baseline CMR to 6 months after procedure
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Difference in 6-Month Left Ventricular Ejection Fraction by Baseline Late Gadolinium Enhancement Presence
Periodo de tiempo: From baseline CMR to 6 months after procedure
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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.
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From baseline CMR to 6 months after procedure
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Correlation Between Baseline CMR-Derived Extracellular Volume and 6-Month Left Ventricular End-Systolic Volume Index
Periodo de tiempo: From baseline CMR to 6 months after procedure
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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.
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From baseline CMR to 6 months after procedure
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
19 de febrero de 2025
Finalización primaria (Estimado)
1 de agosto de 2027
Finalización del estudio (Estimado)
1 de agosto de 2027
Fechas de registro del estudio
Enviado por primera vez
16 de marzo de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de mayo de 2026
Publicado por primera vez (Actual)
26 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- STUDY00003584
- 1R56HL175516-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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