Clinical trial NCT06646224: Efficacy and Safety of the CorVad Percutaneous Ventricular Assist System in Cardiogenic Shock
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiogenic Shock
Lead sponsor: Shenzhen Core Medical Technology CO.,LTD.
Sponsor class: INDUSTRY
First posted: 2024-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety and effectiveness of the CorVad Percutaneous Ventricular Assist System for providing circulatory support in patients with cardiogenic shock caused by cardiomyopathy. This will be assessed through a prospective, multicenter, single-arm clinical trial involving patients with cardiogenic shock. The focus will be on determining the device's ability to improve survival outcomes and reduce the risk of related adverse events in these patients.

Detailed description: This prospective, multicenter, single-arm clinical trial of the CorVad Percutaneous Ventricular Assist System is designed to measure the survival rate of subjects. The survival rate is defined as follows:

* 1. Recovery: Survival at 30 days post-device removal or at discharge (whichever is longer);
* 2. Bridge to Other Therapy: Survival at 30 days post-heart transplantation or left ventricular assist device (LVAD) implantation.

The study plans to enroll 50 subjects. The target population consists of patients with cardiogenic shock caused by cardiomyopathy who provide informed consent through a form approved by the Ethics Committee (EC). Subjects who meet the enrollment criteria, as determined by the investigator, will receive the trial device in accordance with study requirements and will be followed up to assess the primary endpoint.

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.

Primary outcomes:
measure: Survival Rate of Subjects
timeFrame: Recovery: 30 days post-CorVad removal or discharge (which is longer); Bridge to Other Therapy: 30 days post-heart transplantation or LVAD implantation
Secondary outcomes:
measure: In-Hospital Mortality Rate
timeFrame: 30 days post-CorVad removal or discharge (which is longer)
measure: 14-Day Mortality Rate After CorVad Removal
timeFrame: 14 days post-CorVad removal
measure: Stroke
timeFrame: Within 30 days post-CorVad removal
measure: Cardiovascular-Cause Mortality
timeFrame: Within 30 days post-CorVad removal
measure: Re-Hospitalization Due to Cardiovascular Reasons
timeFrame: Within 30 days post-CorVad removal
measure: MCS-ARC Type 3, 4, 5 Bleeding
timeFrame: Within 30 days post-CorVad removal
measure: Serious Device-Related Adverse Events
timeFrame: Within 30 days post-CorVad removal
measure: Duration of Device Use
timeFrame: Recovery: 30 days post-CorVad removal or discharge (which is longer); Bridge to Other Therapy: 30 days post-heart transplantation or LVAD implantation
measure: Device Malfunction
timeFrame: During CorVad operation
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Fuwai Hospital Chinese Academy of Medical Sciences.Shenzhen
state: Guangdong
Study officials:
References: