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

2026年5月6日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Fujian
      • Fuzhou、Fujian、中国

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：SynFlow Duro
デバイス：SynFlow Duro
a novel micro-axial flow pump for temporary left ventricular assistance

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Device support success
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Technical success rate
時間枠：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
時間枠：Through device explantation, up to 14 days
Time from device startup to device explanation
Through device explantation, up to 14 days
Time to recovery
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Within 24 hours after device startup
Within 24 hours after device startup
Cardiac output change versus baseline
時間枠：Within 24 hours after device startup
Within 24 hours after device startup
Pulmonary artery pressure change versus baseline
時間枠：Within 24 hours after device startup
Within 24 hours after device startup
Mean arterial pressure change versus baseline
時間枠：Within 24 hours after device startup
Within 24 hours after device startup
Central venous pressure change versus baseline
時間枠：Within 24 hours after device startup
Within 24 hours after device startup

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

ForQaly Medical (Shanghai) Co., Ltd

捜査官

  • スタディチェア：Liangwan Chen、Fujian Medical University Union Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年5月1日

一次修了 (推定)

2027年6月1日

研究の完了 (推定)

2027年6月1日

試験登録日

最初に提出

2026年4月19日

QC基準を満たした最初の提出物

2026年4月23日

最初の投稿 (実際)

2026年4月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月11日

QC基準を満たした最後の更新が送信されました

2026年5月6日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • CSPR001

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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