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Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock (COURAGE)

6 de maio de 2026 atualizado por: ForQaly Medical (Shanghai) Co., Ltd

Efficacy and Safety of SynFlow Duro System in the Treatment of Post Cardiotomy Cardiogenic Shock: a Prospective, Multicenter, Single-arm Clinical Trial

This study is a prospective, multicenter, single-arm clinical trial conducted in China to evaluate the efficacy and safety of a novel left ventricular assist device, SynFlow Duro system, manufactured by ForQaly Medical in the treatment of post cardiotomy cardiogenic shock.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This study is a prospective, single-arm clinical trial to be conducted in at least 2 centers in China to evaluate the efficacy an safety of a novel micro-axial flow pump for left ventricular assistance in post cardiotomy cardiogenic shock. The trial population includes those who fail to wean from cardiopulmonary bypass OR have refractory cardiogenic shock after cardiac surgery. Patients with right heart failure will be excluded. Eligible subjects will receive SynFlow system for bridging to cardiac recovery or durable cardiac therapy (cardiac transplantation or implantation of approved Ventricular Assist Device). The primary endpoint is device support success, defined as survival to 30 days post-explant or hospital discharge (whichever is longer) OR to explantation in case of bridging to durable cardiac therapies.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

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

Locais de estudo

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

Descrição

Inclusion Criteria:

  • 18≤Age≤80, any sex.
  • Failure to wean from CPB or refractory cardiogenic shock after cardiac surgery.

Failure to wean from CPB is defined as failed to discontinue CPB or post-weaning CI <2.2L/min/m2 + PCWP >15mmHg, despite optimal pre-weaning management and receiving at least one high dose inotrope.

Refractory cardiogenic shock is defined as a condition that occurs despite adequate fluid status and meets all the following criteria:

① CI<2.2L/min/m2 + PCWP>15mmHg despite receiving at least one high dose inotrope or IABP; OR SBP <80mmHg or MAP<50mmHg despite receiving at least one high dose intrope + high dose norepinephrine or IABP.

② Presence of at least one signs indicating hypoperfusion: decreased mentation; cold, clammy, ashen or cyanotic extremities or skin or livedo reticularis; urine output<30ml/h or 0.5ml/kg/h; or lactate>2mmol/L or metabolic acidosis.

- Patient has signed the informed consent form.

Exclusion Criteria:

  • Body surface area>2.5m2.
  • Presence of any cardiac assist device (other than an IABP).
  • Right ventricular failure.
  • Evidence of any vascular disease or anatomy precluding placement or deployment of the device (e.g. severely calcified vessel).
  • Evidence of ventricular thrombus.
  • Moderate or severe aortic valve insufficiency/stenosis, or severe aortic valve calcification.
  • Presence of mechanical aortic valve or cardiac contractile device.
  • Obstructive, hypertrophic cardiomyopathy.
  • Presence of uncorrected ventricular septal defect, atrial septal defect or patent foramen ovale.
  • Mechanical manifestation of AMI (e.g. ventricular septal rupture, papillary muscle rupture, ventricular rupture).
  • Any hematological disorder causing fragility of blood vessel or hemolysis.
  • Known allergy or intolerant to heparin.
  • Presence or suspicion of active systemic infection.
  • Cardiopulmonary resuscitative maneuver lasting longer than 20 minutes before device placement.
  • Sustained or non-sustained ventricular tachycardia or ventricular fibrillation unresponsive to medical therapy.
  • Severe hepatic dysfunction, renal failure or severe respiratory failure
  • Pregnant or lactating female.
  • Concomitant enrollment in another investigational drug or device study where the primary endpoint has not yet been completed or that will clinically interfere with the endpoint of this investigation.
  • Other conditions considered unsuitable for participating in this investigation by the investigators.

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

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: SynFlow Duro
Dispositivo: SynFlow Duro
a novel micro-axial flow pump for temporary left ventricular assistance

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Device support success
Prazo: Up to 30 days post-explant or hospital discharge (whichever is longer)
Cardiac recovery (survival to 30 days post-explant or hospital discharge [which is longer] without other mechanical support including IABP) or briging to other durable cardiac therapies (heart transplantation or implantation of approved durable ventricular assist device)
Up to 30 days post-explant or hospital discharge (whichever is longer)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Technical success rate
Prazo: Through device explantation, up to 14 days
Technical success is defined as successful device placement, deployment, startup and explantation without any device malfunction
Through device explantation, up to 14 days
Device support duration
Prazo: Through device explantation, up to 14 days
Time from device startup to device explanation
Through device explantation, up to 14 days
Time to recovery
Prazo: From device placement to 30 days post-explant or hospital discharge (whichever is longer)
Recovery is defined as survival to 30 days post-explant or hospital discharge (which is longer) without other mechanical support including IABP
From device placement to 30 days post-explant or hospital discharge (whichever is longer)
Major adverse event
Prazo: From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
Defined as stroke or death
From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
Minor adverse event
Prazo: From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
Defined as minor or major bleeding, hemolysis, limb ischemia, requiring continuous renal placement therapy, ventricular tachycardia or fibrillation requiring cardioversion, sepsis, mechanical complications and major access vascular complications.
From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
Adverse event
Prazo: From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
Defined as untoward medical event occurring during the course of clinical investigation, whether or not related to the medical device.
From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
Serious adverse event
Prazo: From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
Defined as the event occurring during the course of clinical investigation, which leads to death or serious deterioration in the health, including a life-threatening illness or injury; a permanent impairment of a body structure or a body function; in-patient or prolonged hospitalization; medical or surgical intervention to prevent permanent impairment to a body structure or a body function; foetal distress, foetal death, congenital abnormality or birth defect, etc.
From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
Device deficiency
Prazo: Through device explantation, up to 14 days
Defined as the unreasonable risk that may endanger human health and life safety in the normal use of medical devices during clinical investigations, such as labeling errors, quality problems, malfunctions, etc.
Through device explantation, up to 14 days
Cardiac index change versus baseline
Prazo: Within 24 hours after device startup
Within 24 hours after device startup
Cardiac output change versus baseline
Prazo: Within 24 hours after device startup
Within 24 hours after device startup
Pulmonary artery pressure change versus baseline
Prazo: Within 24 hours after device startup
Within 24 hours after device startup
Mean arterial pressure change versus baseline
Prazo: Within 24 hours after device startup
Within 24 hours after device startup
Central venous pressure change versus baseline
Prazo: Within 24 hours after device startup
Within 24 hours after device startup

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

ForQaly Medical (Shanghai) Co., Ltd

Investigadores

  • Cadeira de estudo: Liangwan Chen, Fujian Medical University Union Hospital

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)

1 de maio de 2026

Conclusão Primária (Estimado)

1 de junho de 2027

Conclusão do estudo (Estimado)

1 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

19 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de abril de 2026

Primeira postagem (Real)

30 de abril de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CSPR001

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 .

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