Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation (MASTER-TAVI II)
28 de maio de 2026 atualizado por: Josep Rodes-Cabau
Evaluation of a Treatment Algorithm for the Management of TAVI Patients With Significant Concomitant Mitral or Tricuspid Regurgitation
Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk.
Many patients undergoing TAVI also have leakage of the mitral valve and/or tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat.
In some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures.
This study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and/or tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve.
The study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and/or tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up.
The main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life.
The results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.
Visão geral do estudo
Status
Ainda não está recrutando
Tipo de estudo
Observacional
Inscrição (Estimado)
300
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: Melanie Côté, MSc
- Número de telefone: 2646 4186568711
- E-mail: melanie.cote@criucpq.ulaval.ca
Estude backup de contato
- Nome: Josep Rodes Cabau, MD PhD
- Número de telefone: 5593 14186568711
- E-mail: josep.rodes@criucpq.ulaval.ca
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 will consist of adult patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) who also present with significant concomitant mitral regurgitation and/or tricuspid regurgitation. The study will mainly include elderly patients and patients considered at intermediate, high, or prohibitive surgical risk for conventional open-heart surgery.
Eligible participants will have moderate-to-severe or severe mitral and/or tricuspid valve regurgitation identified by echocardiography before TAVI. Patients will be evaluated and treated according to a staged transcatheter treatment algorithm based on current clinical guidelines and the evolution of valve disease following TAVI.
Descrição
Inclusion Criteria:
- Age >18 years.
- Patients with severe AS undergoing transarterial TAVI.
- Concomitant significant MR and/or TR (≥3+).
Exclusion Criteria:
- Life expectancy <1 year due to noncardiac conditions.
- Any prior mitral or tricuspid valve surgery.
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Active endocarditis.
- Subjects in whom transesophageal echocardiography is contraindicated or high risk.
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 |
|---|
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Concomitant isolated MR - 3+ or 4
Patients with severe aortic stenosis (AS) and significant mitral regurgitation (MR) undergoing TAVI followed, if needed, by mitral intervention (M-TEER).
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Concomitant isolated TR - 3+ to 5
Patients with severe AS and significant tricuspid regurgitation (TR) undergoing TAVI followed, if needed, by tricuspid intervention (T-TEER).
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Concomitant MR and TR
Patients with severe AS, MR, and TR undergoing staged triple-valve transcatheter therapy.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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All-cause mortality or re-hospitalization for worsening heart failure
Prazo: Minimum of 1 year
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Composite of all-cause mortality or re-hospitalization for worsening heart failure at a minimum of 1 year following the TAVI procedure
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Minimum of 1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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All-cause mortality or re-hospitalization for worsening heart failure
Prazo: 1 Year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at 1-year follow-up.
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1 Year
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All-cause mortality or re-hospitalization for worsening heart failure
Prazo: 2 year
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Composite of all-cause mortality or re-hospitalization for worsening heart failure at 2-year follow-up
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2 year
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All-cause mortality or re-hospitalization for worsening heart failure
Prazo: 3 year
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Composite of all-cause mortality or re-hospitalization for worsening heart failure at 3-year follow-up.
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3 year
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All-cause mortality or re-hospitalization for worsening heart failure
Prazo: 4 year
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Composite of all-cause mortality or re-hospitalization for worsening heart failure at 4-year follow-up.
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4 year
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All-cause mortality or re-hospitalization for worsening heart failure
Prazo: 5 year
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Composite of all-cause mortality or re-hospitalization for worsening heart failure at 5-year follow-up.
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5 year
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All-cause mortality
Prazo: 1 year
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All-cause mortality at 1 year
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1 year
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All-cause mortality
Prazo: 2 year
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All-cause mortality at 2 year
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2 year
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All-cause mortality
Prazo: 3 year
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All-cause mortality at 3 year
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3 year
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All-cause mortality
Prazo: 4 year
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All-cause mortality at 4 year
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4 year
|
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All-cause mortality
Prazo: 5 year
|
All-cause mortality at 5 year
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5 year
|
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Heart failure re-hospitalization
Prazo: 1 year
|
Heart failure re-hospitalization at 1 year
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1 year
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Heart failure re-hospitalization
Prazo: 2 year
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Heart failure re-hospitalization at 2 year
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2 year
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Heart failure re-hospitalization
Prazo: 3 year
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Heart failure re-hospitalization at 3 year
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3 year
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Heart failure re-hospitalization
Prazo: 4 year
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Heart failure re-hospitalization at 4 year
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4 year
|
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Heart failure re-hospitalization
Prazo: 5 year
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Heart failure re-hospitalization at 5 year
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5 year
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Cardiovascular mortality
Prazo: 1 year
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Cardiovascular mortality at 1 year
|
1 year
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Cardiovascular mortality
Prazo: 2 year
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Cardiovascular mortality at 2 year
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2 year
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Cardiovascular mortality
Prazo: 3 year
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Cardiovascular mortality at 3 year
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3 year
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Cardiovascular mortality
Prazo: 4 year
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Cardiovascular mortality at 4 year
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4 year
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Cardiovascular mortality
Prazo: 5 year
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Cardiovascular mortality at 5 year
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5 year
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All-cause mortality or heart failure re-hospitalization
Prazo: 1 year
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Evaluation of the composite outcome (all-cause mortality or heart failure re-hospitalization) at 1-year follow-up compared with a historical cohort.
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1 year
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MR severity
Prazo: 1 year
|
MR severity at 1 year
|
1 year
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MR severity
Prazo: 2 year
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MR severity at 2 year
|
2 year
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MR severity
Prazo: 3 year
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MR severity at 3 year
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3 year
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MR severity
Prazo: 4 year
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MR severity at 4 year
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4 year
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MR severity
Prazo: 5 year
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MR severity at 5 year
|
5 year
|
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TR severity
Prazo: 1 year
|
TR severity at 1 year
|
1 year
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TR severity
Prazo: 2 year
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TR severity at 2 year
|
2 year
|
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TR severity
Prazo: 3 year
|
TR severity at 3 year
|
3 year
|
|
TR severity
Prazo: 4 year
|
TR severity at 4 year
|
4 year
|
|
TR severity
Prazo: 5 year
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TR severity at 5 year
|
5 year
|
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LVEF
Prazo: 1 year
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LVEF at 1 year
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1 year
|
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LVEF
Prazo: 2 year
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LVEF at 2 year
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2 year
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LVEF
Prazo: 3 year
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LVEF at 3 year
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3 year
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LVEF
Prazo: 4 year
|
LVEF at 4 year
|
4 year
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LVEF
Prazo: 5 year
|
LVEF at 5 year
|
5 year
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Josep Rodes Cabau, MD PhD, IUCPQ-UL
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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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 (Estimado)
5 de junho de 2026
Conclusão Primária (Estimado)
5 de junho de 2029
Conclusão do estudo (Estimado)
5 de junho de 2034
Datas de inscrição no estudo
Enviado pela primeira vez
28 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de maio de 2026
Primeira postagem (Real)
3 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MASTER-TAVI II
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data (IPD) will not be publicly shared due to patient confidentiality and privacy considerations, as well as institutional and ethical restrictions governing the use of clinical research data.
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 .