Evaluating a new device for heart support in patients with severe heart failure

A Clinical Trial to Evaluate the Efficacy and Safety of the CorVad Percutaneous Ventricular Assist System in the Treatment of Cardiogenic Shock Caused by Cardiomyopathy

This study is testing a new heart support device to see if it can help critically ill patients with severe heart failure live longer and have fewer complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shenzhen Core Medical Technology CO.,LTD. (Industry-sponsored)
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT06646224 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety and effectiveness of the CorVad Percutaneous Ventricular Assist System in patients experiencing cardiogenic shock due to cardiomyopathy. It is a prospective, multicenter, single-arm trial that aims to determine the device's ability to improve survival outcomes and reduce adverse events. The study will enroll 50 subjects who meet specific inclusion criteria and will follow them to evaluate survival rates at key time points post-device removal or discharge. The primary focus is on patients who are critically ill and require circulatory support.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with cardiogenic shock caused by cardiomyopathy and specific hemodynamic instability criteria.

Not a fit: Patients with cardiogenic shock not caused by cardiomyopathy or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could significantly improve survival rates and quality of life for patients suffering from cardiogenic shock.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using ventricular assist devices for severe heart failure, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 1\. Age of subjects must be between 18 and 80 years old (inclusive).
* 2\. Presence of heart failure or cardiac dysfunction caused by cardiomyopathy.
* 3\. Occurrence of cardiogenic shock under adequate blood volume, which must meet one of the following conditions:

  1. Rapidly Worsening Cardiogenic Shock: Progressive hemodynamic instability requiring repeated administration of vasopressors to maintain mean arterial pressure \>50 mmHg, and left ventricular systolic function is impaired (LVEF \<35% or LVEF 35-55% with significant mitral regurgitation).
  2. Severe Cardiogenic Shock: Cardiac index (CI) \< 2.2 L/min/m² + norepinephrine dose \> 0.1 µg/kg/min + dopamine or dobutamine dose \> 10 µg/kg/min; systolic blood pressure \< 90 mmHg + norepinephrine dose \> 0.2 µg/kg/min + dopamine or dobutamine dose \> 10 µg/kg/min + LVEF \< 35% or LVEF 35-55% with significant mitral regurgitation.
* 4\. Two consecutive blood lactate measurements ≥ 3.0 mmol/L (with at least a 30-minute interval).
* 5\. The subject or their guardian must be able to understand the purpose of the trial, sign the informed consent form, demonstrate good compliance after discharge, and be willing to complete clinical follow-up.

Exclusion Criteria:

* 1\. Continuous cardiopulmonary resuscitation (CPR) cannot restore circulation.
* 2\. CorVad cannot be implanted or applied (including but not limited to left ventricular mural thrombus, presence of artificial aortic valve or cardiac contraction devices, moderate to severe aortic stenosis, moderate to severe aortic regurgitation, aortic dissection, aneurysm, or severe abnormalities of the ascending aorta and/or aortic arch, blood cell fragility, or hemolytic blood disorders).
* 3\. Inability to use heparin for anticoagulation therapy.
* 4\. Shock caused by other reasons (e.g., myocardial infarction, arrhythmia, hypovolemia, septic shock, etc.).
* 5\. Presence of unrepaired cardiac structural damage (e.g., chordal rupture, ventricular septal perforation, free wall rupture, etc.).
* 6\. Severe right heart failure.
* 7\. Pregnant or breastfeeding women.
* 8\. Currently participating in another clinical trial of a drug or device that has not yet reached its primary endpoint.
* 9\. Any other circumstances deemed inappropriate for inclusion in this study by the investigator.

Where this trial is running

Shenzhen, Guangdong

• Fuwai Hospital Chinese Academy of Medical Sciences.Shenzhen — Shenzhen, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Xiaoli Shi

Conditions Cardiogenic Shock