Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock (COURAGE)
2026년 5월 6일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Chen Jiang
- 전화번호: +86 13918357410
- 이메일: cjiang@forqaly.com
연구 장소
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Fujian
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Fuzhou, Fujian, 중국
- Fujian Medical University Union Hospital
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연락하다:
- Liangwan Chen
- 이메일: chenliangwan@fjmu.edu.cn
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: SynFlow Duro
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a novel micro-axial flow pump for temporary left ventricular assistance
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Device support success
기간: Up to 30 days post-explant or hospital discharge (whichever is longer)
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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)
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Up to 30 days post-explant or hospital discharge (whichever is longer)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Technical success rate
기간: Through device explantation, up to 14 days
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Technical success is defined as successful device placement, deployment, startup and explantation without any device malfunction
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Through device explantation, up to 14 days
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Device support duration
기간: Through device explantation, up to 14 days
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Time from device startup to device explanation
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Through device explantation, up to 14 days
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Time to recovery
기간: From device placement to 30 days post-explant or hospital discharge (whichever is longer)
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Recovery is defined as survival to 30 days post-explant or hospital discharge (which is longer) without other mechanical support including IABP
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From device placement to 30 days post-explant or hospital discharge (whichever is longer)
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Major adverse event
기간: From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
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Defined as stroke or death
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From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
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Minor adverse event
기간: From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
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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.
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From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
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Adverse event
기간: From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
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Defined as untoward medical event occurring during the course of clinical investigation, whether or not related to the medical device.
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From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
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Serious adverse event
기간: From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
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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.
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From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
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Device deficiency
기간: Through device explantation, up to 14 days
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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.
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Through device explantation, up to 14 days
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Cardiac index change versus baseline
기간: Within 24 hours after device startup
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Within 24 hours after device startup
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Cardiac output change versus baseline
기간: Within 24 hours after device startup
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Within 24 hours after device startup
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Pulmonary artery pressure change versus baseline
기간: Within 24 hours after device startup
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Within 24 hours after device startup
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Mean arterial pressure change versus baseline
기간: Within 24 hours after device startup
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Within 24 hours after device startup
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Central venous pressure change versus baseline
기간: Within 24 hours after device startup
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Within 24 hours after device startup
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Liangwan Chen, Fujian Medical University Union Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 1일
기본 완료 (추정된)
2027년 6월 1일
연구 완료 (추정된)
2027년 6월 1일
연구 등록 날짜
최초 제출
2026년 4월 19일
QC 기준을 충족하는 최초 제출
2026년 4월 23일
처음 게시됨 (실제)
2026년 4월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 6일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
심인성 쇼크에 대한 임상 시험
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Centre Hospitalier Universitaire Dijon모병Norepinephrine-retractory vasoplegic shock 환자프랑스
SynFlow Duro에 대한 임상 시험
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ForQaly Medical (Shanghai) Co., Ltd완전한관상 동맥 질환(CAD) | 고위험 PCI중국