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

NCT06646224 | Recruiting

• 1 other identifier: COREMED_Corvad_CMCS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Shock

Outcome Measures

Primary Outcomes (1)

• Survival Rate of Subjects

  Survival is defined as: 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.

  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 (9)

• 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

  Within 30 days post-CorVad removal

Study Arms (1)

CorVad Percutaneous Ventricular Assist System

EXPERIMENTAL

Subjects with cardiogenic shock caused by cardiomyopathy will be supported by the CorVad Percutaneous Ventricular Assist System

Device: CorVad Percutaneous Ventricular Assist System

Interventions

CorVad Percutaneous Ventricular Assist System DEVICE

The CorVad Percutaneous Ventricular Assist System provides circulatory support for patients with cardiogenic shock.

CorVad Percutaneous Ventricular Assist System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age of subjects must be between 18 and 80 years old (inclusive).
• \. Presence of heart failure or cardiac dysfunction caused by cardiomyopathy.
• \. Occurrence of cardiogenic shock under adequate blood volume, which must meet one of the following conditions:
• 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).
• 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.
• \. Two consecutive blood lactate measurements ≥ 3.0 mmol/L (with at least a 30-minute interval).
• \. 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.

You may not qualify if:

• \. Continuous cardiopulmonary resuscitation (CPR) cannot restore circulation.
• \. 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).
• \. Inability to use heparin for anticoagulation therapy.
• \. Shock caused by other reasons (e.g., myocardial infarction, arrhythmia, hypovolemia, septic shock, etc.).
• \. Presence of unrepaired cardiac structural damage (e.g., chordal rupture, ventricular septal perforation, free wall rupture, etc.).
• \. Severe right heart failure.
• \. Pregnant or breastfeeding women.
• \. Currently participating in another clinical trial of a drug or device that has not yet reached its primary endpoint.

Sponsors & Collaborators

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

Study Sites (1)

Fuwai Hospital Chinese Academy of Medical Sciences.Shenzhen

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Central Study Contacts

Xiaoli Shi

CONTACT

+86 13418601356; shixiaoli@coretechmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 17, 2024
• Study Start: October 12, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)