Safety and Efficacy of an Extracorporeal Ventricular Assist System for Cardiogenic Shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm study enrolling 40 adults with cardiogenic shock or weaning difficulty from cardiopulmonary bypass. It assesses temporary mechanical circulatory support using an extracorporeal ventricular assist system and tracks safety as well as how well the device enables transition to long-term therapy such as VAD or transplant. Primary outcome is the success rate of mechanical circulatory support; secondary outcomes include 30-day survival after transition, 30-day mortality after explant, MACCE, duration of support, and rates of bleeding, thrombosis, renal/hepatic dysfunction, and infection. The study also evaluates device components including the pump head, cannulae, and tubing. The design is a prospective, multicenter, single-arm target-value study to validate a Class III medical device.

Why it matters

Who can join: the full rules

Inclusion Criteria:(1) The subject voluntarily participates in the study and has signed the informed consent form; (2) Age ≥ 18 years; (3) Subjects diagnosed with cardiogenic shock or low cardiac output syndrome meeting one of the following clinical scenarios: Unstable circulation secondary to low cardiac output after cardiac surgery, or inability to wean from cardiopulmonary bypass during surgery; Acute decompensation of heart failure (including ischemic cardiomyopathy, dilated cardiomyopathy, etc.) with persistent hemodynamic instability despite conventional pharmacotherapy and IABP support; Hemodynamic instability in patients with end-stage heart failure prior to heart transplantation or transition to other long-term therapeutic strategies.

(4) Cardiogenic shock shall meet the following criteria:

Signs of inadequate perfusion (at least one item):

① Altered mental status unexplainable by other causes: agitation in the early stage, lethargy and stupor in the late stage;

* Cool, clammy and mottled skin of extremities; ③ Oliguria (\<30 mL/h or 0.5 mL/kg/h).

Hypotension with adequate intravascular volume (at least one item):

* Systolic blood pressure ≤90 mmHg or mean arterial pressure ≤60 mmHg lasting more than 30 minutes; ② Requirement for vasoactive agents or inotropic agents to maintain systolic blood pressure ≥90 mmHg; ③ Systolic blood pressure ≥90 mmHg after excluding trauma, intoxication, hypoxia and other factors, accompanied by obvious manifestations of hypoperfusion.

Laboratory or hemodynamic findings (at least one item):

* Hemodynamics: Cardiac Index (CI) ≤2.2 L/min·m², Pulmonary Capillary Wedge Pressure (PCWP) ≥15 mmHg;

  * Laboratory test: Lactate ≥2 mmol/L; ③ Serum creatinine increased to 1.5 times the baseline value, or glomerular filtration rate decreased by \>50%; ④ ALT elevated to 3 times the upper limit of normal. (5) Authorized clinicians confirm that all feasible measures have been implemented to correct abnormalities of arterial blood gas, electrolyte disorders, hypovolemia, hypervolemia, bradycardia, arrhythmia and incomplete rewarming.

Exclusion Criteria:

* (1) Patients who fail to comply with medical treatment protocols; (2) Patients with established irreversible central nervous system injury; (3) Patients intolerant to anticoagulants (such as heparin or equivalent alternatives); (4) Patients with severe infection, malignant tumor, or end-stage multiple organ failure; (5) Patients with implanted mechanical heart valves, moderate to severe aortic regurgitation, or unrepaired structural cardiac lesions (e.g., ventricular septal rupture); (6) Patients with severe peripheral vascular disease or irreversible neurological/neuromuscular disorders; (7) Patients with pulmonary embolism, pulmonary infarction, or uncorrectable pulmonary hypertension; (8) Patients with psychiatric disorders requiring long-term standardized treatment or relevant medical history, drug abusers, and patients positive for HIV or syphilis; (9) Patients with a history of stroke or transient ischemic attack (TIA) within the past 3 months; (10) Patients with active bleeding or disorders of coagulation; (11) Female patients during pregnancy; (12) Patients who have participated in another clinical trial within 1 month, or are currently participating in another clinical trial that has not reached its endpoint; (13) Patients with other conditions deemed ineligible for this trial by the investigator.

Where it's running

• Fuwai Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: xianqiang wang
• Email: wangxianqiang@fuwai.com
• Phone: 13331006960

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.