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

6 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: SynFlow Duro
Dispositivo: SynFlow Duro
a novel micro-axial flow pump for temporary left ventricular assistance

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Device support success
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Technical success rate
Lasso di tempo: 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
Lasso di tempo: Through device explantation, up to 14 days
Time from device startup to device explanation
Through device explantation, up to 14 days
Time to recovery
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Within 24 hours after device startup
Within 24 hours after device startup
Cardiac output change versus baseline
Lasso di tempo: Within 24 hours after device startup
Within 24 hours after device startup
Pulmonary artery pressure change versus baseline
Lasso di tempo: Within 24 hours after device startup
Within 24 hours after device startup
Mean arterial pressure change versus baseline
Lasso di tempo: Within 24 hours after device startup
Within 24 hours after device startup
Central venous pressure change versus baseline
Lasso di tempo: Within 24 hours after device startup
Within 24 hours after device startup

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

ForQaly Medical (Shanghai) Co., Ltd

Investigatori

  • Cattedra di studio: Liangwan Chen, Fujian Medical University Union Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 giugno 2027

Date di iscrizione allo studio

Primo inviato

19 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 aprile 2026

Primo Inserito (Effettivo)

30 aprile 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CSPR001

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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