CorVad Ventricular Assist System for Cardiogenic Shock in Cardiomyopathy
CorVad Percutaneous Ventricular Assist System
Cardiovascular Diseases+9
+ Heart Diseases
+ Infarction
Treatment Study
Summary
Study start date: October 12, 2024
Actual date on which the first participant was enrolled.This clinical trial focuses on evaluating a new device, the CorVad Percutaneous Ventricular Assist System, which aims to help patients suffering from cardiogenic shock due to cardiomyopathy. Cardiogenic shock is a condition where the heart suddenly can't pump enough blood, and cardiomyopathy is a disease of the heart muscle. The goal is to determine how effective and safe this device is in improving the survival rates of these patients. This study is important because it seeks to address a serious health issue that currently has limited treatment options, potentially offering a new way to help patients recover or prepare for further treatments like heart transplants. Participants in this study will receive the CorVad device, which is used to support the heart temporarily. The study will measure success by looking at how many patients survive either 30 days after the device is removed or after being discharged from the hospital, whichever is longer. Additionally, it checks survival rates 30 days after receiving further treatments like a heart transplant or another heart-assisting device. As part of the trial, 50 patients who meet specific criteria will be enrolled and will need to provide informed consent. The study will closely monitor these patients to ensure safety and assess the effectiveness of the device.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fuwai Hospital Chinese Academy of Medical Sciences.Shenzhen
Shenzhen, ChinaOpen Fuwai Hospital Chinese Academy of Medical Sciences.Shenzhen in Google Maps