Efficacy and Safety of the CorVad Percutaneous Ventricular Assist System in Cardiogenic Shock

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 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.

Study Overview

• Status: Recruiting
• Conditions: Cardiogenic Shock
• Intervention / Treatment: Device: CorVad Percutaneous Ventricular Assist System

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoli Shi; Phone Number: +86 13418601356; Email: shixiaoli@coretechmed.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China
      • Recruiting
      • Fuwai Hospital Chinese Academy of Medical Sciences.Shenzhen
      • Contact: Haibo Chen; Phone Number: +86 18910171249; Email: chenhaibo@fuwaihaopital.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CorVad Percutaneous Ventricular Assist System; Subjects with cardiogenic shock caused by cardiomyopathy will be supported by the CorVad Percutaneous Ventricular Assist System	Device: CorVad Percutaneous Ventricular Assist System; The CorVad Percutaneous Ventricular Assist System provides circulatory support for patients with cardiogenic shock.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival Rate of Subjects	Survival is defined as: Recovery: Survival at 30 days post device removal or at discharge (whichever is longer);; Bridge to Other Therapy: Survival at 30 days post heart transplantation or left ventricular assist device (LVAD) implantation.	Recovery: 30 days post-CorVad removal or discharge (which is longer); Bridge to Other Therapy: 30 days post-heart transplantation or LVAD implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-Hospital Mortality Rate		30 days post-CorVad removal or discharge (which is longer)
14-Day Mortality Rate After CorVad Removal		14 days post-CorVad removal
Stroke		Within 30 days post-CorVad removal
Cardiovascular-Cause Mortality		Within 30 days post-CorVad removal
Re-Hospitalization Due to Cardiovascular Reasons	Re-hospitalization for cardiovascular disease	Within 30 days post-CorVad removal
MCS-ARC Type 3, 4, 5 Bleeding		Within 30 days post-CorVad removal
Serious Device-Related Adverse Events	Serious device-related adverse events include but are not limited to cardiac structural damage, severe limb ischemia (pallor, pulselessness, and necrosis), puncture site infection, acute kidney injury, arrhythmias requiring cardiopulmonary resuscitation, damage to the aorta and aortic valve, hemolysis resulting in subject death, permanent or serious disability, significantly prolonged hospital stay, or surgical intervention required.	Within 30 days post-CorVad removal
Duration of Device Use		Recovery: 30 days post-CorVad removal or discharge (which is longer); Bridge to Other Therapy: 30 days post-heart transplantation or LVAD implantation
Device Malfunction	Device malfunction is defined as a flow rate of less than 1L/min at S5 or higher speed level lasting more than 5 minutes	During CorVad operation

Collaborators and Investigators

• Sponsor: Shenzhen Core Medical Technology CO.,LTD.

Study record dates

Study Major Dates

• Study Start (Estimated): October 12, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Shock; Shock, Cardiogenic
• Other Study ID Numbers: COREMED_Corvad_CMCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At this moment the IPD is not yet available for access and will be updated when it is ready.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No