VitaFlow LIBERTY Europa
Estudo de acompanhamento clínico pós-comercialização do sistema de válvula aórtica transcateter 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Zhujun Cai, PhD
- Número de telefone: 86-021-38954600
- E-mail: zjcai@microport.com
Estude backup de contato
- Nome: Yann Poezevara, PhD
- Número de telefone: 0033-146013409
- E-mail: Yann.Poezevara@cf.microport.com
Locais de estudo
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A Coruña, Espanha
- Recrutamento
- Hospital Universitario de a Coruna
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Contato:
- Dr Pablo Pinon
- Número de telefone: +34 981 17 80 00
- E-mail: info@jjphospitalaria.com
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Madrid, Espanha
- Recrutamento
- Hospital Clínico San Carlos
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Contato:
- Dr.Luis Nombel
- Número de telefone: 91 330 30 00
- E-mail: gerent.hcsc@salud.madrid.org
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Valladolid, Espanha
- Recrutamento
- Hospital clinico Universitario de Valladolid
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Contato:
- Dr. Filippo Pensotti
- Número de telefone: +34 983 42 00 00
- E-mail: ceim.asva@saludcastillayleon.esjalvarezgo
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Galway, Irlanda
- Recrutamento
- Galway University Hospital
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Contato:
- Darren Mylotte, MD
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Castel Volturno, Itália
- Recrutamento
- Pineta Grande Hospital
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Contato:
- Alberto Morello
- Número de telefone: +393397904191
- E-mail: albertomorello83@gmail.com
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Pisa, Itália
- Recrutamento
- Ospedale Cisanello
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Contato:
- Dr.Marco De Carlo
- Número de telefone: +39 050 971 9530
- E-mail: urp@ao-pisa.toscana.it
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Potenza, Itália
- Recrutamento
- Azienda Ospedaliera Regionale -S.Carlo
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Contato:
- Eugenio Stabile
- Número de telefone: +39 81 746 2228/53
- E-mail: eugeniostabile@gmail.com
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Carnaxide, Portugal
- Recrutamento
- Hospital de Santa Cruz
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Contato:
- Rui Teles
- Número de telefone: +351 21 043 1000
- E-mail: rcteles@outlook.com
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Lucerne, Suíça
- Recrutamento
- Luzerner Kantonsspital | Herzzentrum
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Contato:
- Dr.Stefan Toggweiler
- Número de telefone: 0412051111
- E-mail: ifo@luks.ch
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients with symptomatic, severe calcified aortic stenosis who are at high surgical risk.
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Investigação clínica de braço único
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Composite rate of all-cause mortality and stroke with disability
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Safety outcomes defined by VARC3
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Discharge
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Discharge
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Predictors for the permanent pacemaker implantation
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- VitaFlow EU-2024
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