VitaFlow LIBERTY Europa
Estudio de seguimiento clínico poscomercialización del sistema de válvula aórtica transcatéter VitaFlow Liberty ™
This is a prospective, single-arm, multi-center, observational, post-market clinical investigation to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the routine practice for the treatment of severe aortic valve stenosis. The primary endpoint is the composite rate of all-cause mortality and stroke with disability at 12 months.
Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Zhujun Cai, PhD
- Número de teléfono: 86-021-38954600
- Correo electrónico: zjcai@microport.com
Copia de seguridad de contactos de estudio
- Nombre: Yann Poezevara, PhD
- Número de teléfono: 0033-146013409
- Correo electrónico: Yann.Poezevara@cf.microport.com
Ubicaciones de estudio
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A Coruña, España
- Reclutamiento
- Hospital Universitario de a Coruna
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Contacto:
- Dr Pablo Pinon
- Número de teléfono: +34 981 17 80 00
- Correo electrónico: info@jjphospitalaria.com
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Madrid, España
- Reclutamiento
- Hospital Clínico San Carlos
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Contacto:
- Dr.Luis Nombel
- Número de teléfono: 91 330 30 00
- Correo electrónico: gerent.hcsc@salud.madrid.org
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Valladolid, España
- Reclutamiento
- Hospital clinico Universitario de Valladolid
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Contacto:
- Dr. Filippo Pensotti
- Número de teléfono: +34 983 42 00 00
- Correo electrónico: ceim.asva@saludcastillayleon.esjalvarezgo
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Galway, Irlanda
- Reclutamiento
- Galway University Hospital
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Contacto:
- Darren Mylotte, MD
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Castel Volturno, Italia
- Reclutamiento
- Pineta Grande Hospital
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Contacto:
- Alberto Morello
- Número de teléfono: +393397904191
- Correo electrónico: albertomorello83@gmail.com
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Pisa, Italia
- Reclutamiento
- Ospedale Cisanello
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Contacto:
- Dr.Marco De Carlo
- Número de teléfono: +39 050 971 9530
- Correo electrónico: urp@ao-pisa.toscana.it
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Potenza, Italia
- Reclutamiento
- Azienda Ospedaliera Regionale -S.Carlo
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Contacto:
- Eugenio Stabile
- Número de teléfono: +39 81 746 2228/53
- Correo electrónico: eugeniostabile@gmail.com
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Carnaxide, Portugal
- Reclutamiento
- Hospital de Santa Cruz
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Contacto:
- Rui Teles
- Número de teléfono: +351 21 043 1000
- Correo electrónico: rcteles@outlook.com
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Lucerne, Suiza
- Reclutamiento
- Luzerner Kantonsspital | Herzzentrum
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Contacto:
- Dr.Stefan Toggweiler
- Número de teléfono: 0412051111
- Correo electrónico: ifo@luks.ch
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients with symptomatic, severe calcified aortic stenosis who are at high surgical risk.
Descripción
Inclusion Criteria:
- Subjects of age≥ 18 years
- Subjects with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (AVR).
- Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow up requirements.
Exclusion Criteria:
- Pre-existing mechanical heart valve in aortic position
- A known hypersensitivity or contraindication to all anticoagulation /antiplatelet regimens (or inability to be anticoagulated for the index procedure), to nickel or titanium, to nitinol, to dairy products, to polyethylene terephthalate (PET) or contrast media
- Ongoing sepsis, including active endocarditis
- Anatomically not suitable for the VitaFlow Liberty TAV system
- LVEF<20%
- Estimated life expectancy of less than 12 months
- Any medical, social or psychological condition that in the opinion of the Heart Team precludes the subject from receiving transcatheter aortic valve replacement
- Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed
- Inability to comply with the clinical investigation follow-up or other clinical investigation requirements
- Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Investigación clínica de un solo brazo
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Transcatheter Aortic Valve Replacement with VitaFlow Liberty™ Transcatheter Aortic Valve System. Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Composite rate of all-cause mortality and stroke with disability
Periodo de tiempo: 12 months post procedure
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Composite rate of all-cause mortality and stroke with disability |
12 months post procedure
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Safety outcomes defined by VARC3
Periodo de tiempo: 30 days, 12 months, and 2-5 years post procedure
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Rate of all-cause mortality, myocardial infarction, stroke, implanted related new and/or worsen conduction disturbances and arrhythmias, new permanent pacemaker implantation, procedure-related or valve-related hospitalization defined by VARC 3. |
30 days, 12 months, and 2-5 years post procedure
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Safety outcomes defined by VARC3
Periodo de tiempo: 30 days and 12 months post procedure
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Rate of type 2-4 bleeding, major vascular and access-related complications, acute kidney injury (stage 2-4) defined by VARC 3 |
30 days and 12 months post procedure
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Safety outcomes defined by VARC3
Periodo de tiempo: acute procedure (within 24 hours)
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Rate of other acute procedural and technical valve related complications: conversion to surgery; unplanned use of mechanical circulatory support; implantation of multiple (>1) transcatheter valves during the index hospitalization; valve mal-position |
acute procedure (within 24 hours)
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Device success
Periodo de tiempo: 30 days post implantation
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Device success defined by VARC 3 |
30 days post implantation
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Device early safety
Periodo de tiempo: 30 days post implantation
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Device early safety defined by VARC 3 |
30 days post implantation
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Bioprosthesis haemodynamic function
Periodo de tiempo: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
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Bioprosthesis haemodynamic function (assessed by echocardiography) including effective orifice area (cm2). |
Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
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Bioprosthesis haemodynamic function
Periodo de tiempo: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
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Bioprosthesis haemodynamic function (assessed by echocardiography) including mean transvalvular gradient (mmHg). |
Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
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Bioprosthesis haemodynamic function
Periodo de tiempo: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
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Bioprosthesis haemodynamic function (assessed by echocardiography) including aortic regurgitation (paravalvular, central and total). |
Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
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Bioprosthetic valve dysfunction
Periodo de tiempo: 12 months and 2-5 years post procedure
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Moderate or severe haemodynamic valve deterioration defined by VARC3 |
12 months and 2-5 years post procedure
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Bioprosthetic valve dysfunction
Periodo de tiempo: 12 months and 2-5 years post procedure
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Bioprosthetic valve failure defined by VARC3 |
12 months and 2-5 years post procedure
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Bioprosthetic valve dysfunction
Periodo de tiempo: 12 months and 2-5 years post procedure
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Clinically significant valve thrombosis defined by VARC3 |
12 months and 2-5 years post procedure
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NYHA Classification
Periodo de tiempo: From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure
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Changes in cardiac function at discharge, 30 days and 12 months and 2-5 years post implantation according to the NYHA Classification Scheme compared to baseline |
From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure
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Rate of Alwide Plus Balloon Catheter pre-dilation success
Periodo de tiempo: During procedure
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Defined as successful access, delivery and dilation the aortic valve, and retrieval for the AlwideTM Plus balloon catheter |
During procedure
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Alwide Plus Balloon Catheter related adverse-event
Periodo de tiempo: Discharge
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Discharge
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Predictors for the permanent pacemaker implantation
Periodo de tiempo: Baseline or intraprocedure
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Including but not limited to pre-existing conduction disturbance, implant depth, LVOT calcium volume , post-dilatation |
Baseline or intraprocedure
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Darren Mylotte, MD, Galway University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- VitaFlow EU-2024
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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