Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation (MASTER-TAVI II)
28 de mayo de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Tipo de estudio
De observación
Inscripción (Estimado)
300
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: Melanie Côté, MSc
- Número de teléfono: 2646 4186568711
- Correo electrónico: melanie.cote@criucpq.ulaval.ca
Copia de seguridad de contactos de estudio
- Nombre: Josep Rodes Cabau, MD PhD
- Número de teléfono: 5593 14186568711
- Correo electrónico: josep.rodes@criucpq.ulaval.ca
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 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.
Descripción
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.
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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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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All-cause mortality or re-hospitalization for worsening heart failure
Periodo de tiempo: Minimum of 1 year
|
Composite of all-cause mortality or re-hospitalization for worsening heart failure at a minimum of 1 year following the TAVI procedure
|
Minimum of 1 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
All-cause mortality or re-hospitalization for worsening heart failure
Periodo de tiempo: 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
Periodo de tiempo: 2 year
|
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
Periodo de tiempo: 3 year
|
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
Periodo de tiempo: 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
Periodo de tiempo: 5 year
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 3 year
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All-cause mortality at 3 year
|
3 year
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All-cause mortality
Periodo de tiempo: 4 year
|
All-cause mortality at 4 year
|
4 year
|
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All-cause mortality
Periodo de tiempo: 5 year
|
All-cause mortality at 5 year
|
5 year
|
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Heart failure re-hospitalization
Periodo de tiempo: 1 year
|
Heart failure re-hospitalization at 1 year
|
1 year
|
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Heart failure re-hospitalization
Periodo de tiempo: 2 year
|
Heart failure re-hospitalization at 2 year
|
2 year
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Heart failure re-hospitalization
Periodo de tiempo: 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
Periodo de tiempo: 4 year
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Heart failure re-hospitalization at 4 year
|
4 year
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Heart failure re-hospitalization
Periodo de tiempo: 5 year
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Heart failure re-hospitalization at 5 year
|
5 year
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Cardiovascular mortality
Periodo de tiempo: 1 year
|
Cardiovascular mortality at 1 year
|
1 year
|
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Cardiovascular mortality
Periodo de tiempo: 2 year
|
Cardiovascular mortality at 2 year
|
2 year
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Cardiovascular mortality
Periodo de tiempo: 3 year
|
Cardiovascular mortality at 3 year
|
3 year
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Cardiovascular mortality
Periodo de tiempo: 4 year
|
Cardiovascular mortality at 4 year
|
4 year
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Cardiovascular mortality
Periodo de tiempo: 5 year
|
Cardiovascular mortality at 5 year
|
5 year
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All-cause mortality or heart failure re-hospitalization
Periodo de tiempo: 1 year
|
Evaluation of the composite outcome (all-cause mortality or heart failure re-hospitalization) at 1-year follow-up compared with a historical cohort.
|
1 year
|
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MR severity
Periodo de tiempo: 1 year
|
MR severity at 1 year
|
1 year
|
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MR severity
Periodo de tiempo: 2 year
|
MR severity at 2 year
|
2 year
|
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MR severity
Periodo de tiempo: 3 year
|
MR severity at 3 year
|
3 year
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MR severity
Periodo de tiempo: 4 year
|
MR severity at 4 year
|
4 year
|
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MR severity
Periodo de tiempo: 5 year
|
MR severity at 5 year
|
5 year
|
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TR severity
Periodo de tiempo: 1 year
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TR severity at 1 year
|
1 year
|
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TR severity
Periodo de tiempo: 2 year
|
TR severity at 2 year
|
2 year
|
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TR severity
Periodo de tiempo: 3 year
|
TR severity at 3 year
|
3 year
|
|
TR severity
Periodo de tiempo: 4 year
|
TR severity at 4 year
|
4 year
|
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TR severity
Periodo de tiempo: 5 year
|
TR severity at 5 year
|
5 year
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LVEF
Periodo de tiempo: 1 year
|
LVEF at 1 year
|
1 year
|
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LVEF
Periodo de tiempo: 2 year
|
LVEF at 2 year
|
2 year
|
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LVEF
Periodo de tiempo: 3 year
|
LVEF at 3 year
|
3 year
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LVEF
Periodo de tiempo: 4 year
|
LVEF at 4 year
|
4 year
|
|
LVEF
Periodo de tiempo: 5 year
|
LVEF at 5 year
|
5 year
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Josep Rodes Cabau, MD PhD, IUCPQ-UL
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
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- Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.
- Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.
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- Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021 Feb 2;77(4):e25-e197. doi: 10.1016/j.jacc.2020.11.018. Epub 2020 Dec 17. No abstract available.
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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 (Estimado)
5 de junio de 2026
Finalización primaria (Estimado)
5 de junio de 2029
Finalización del estudio (Estimado)
5 de junio de 2034
Fechas de registro del estudio
Enviado por primera vez
28 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de mayo de 2026
Publicado por primera vez (Actual)
3 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MASTER-TAVI II
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
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
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .