Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation (DMR)
18 de maio de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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 estudo
Observacional
Inscrição (Estimado)
60
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Aakriti Gupta, M.D.
- Número de telefone: 267-442-8776
- E-mail: aakriti.gupta@cshs.org
Locais de estudo
-
-
California
-
Los Angeles, California, Estados Unidos, 90048
- Recrutamento
- Smidt Heart Institute, Cedars Sinai Medical Center
-
Contato:
- Aakriti Gupta, M.D.
- Número de telefone: 267-442-8776
- E-mail: aakriti.gupta@cshs.org
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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).
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants With One or More Major Periprocedural or 30-Day Complications
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
19 de fevereiro de 2025
Conclusão Primária (Estimado)
1 de agosto de 2027
Conclusão do estudo (Estimado)
1 de agosto de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
16 de março de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de maio de 2026
Primeira postagem (Real)
26 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
26 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- STUDY00003584
- 1R56HL175516-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .