Cardiogenic ShockNCT06646224
Efficacy and Safety of the CorVad Percutaneous Ventricular Assist System in Cardiogenic Shock
A study testing CorVad Percutaneous Ventricular Assist System in people with Cardiogenic Shock, run by Shenzhen Core Medical Technology CO.,LTD. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- CorVad Percutaneous Ventricular Assist System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital Chinese Academy of Medical Sciences.Shenzhen
Shenzhen, Guangdong
Haibo Chen, +86 18910171249, chenhaibo@fuwaihaopital.org
About this study
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
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.
Read the 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.
- Conditions
- Cardiogenic Shock
- Being tested
- CorVad Percutaneous Ventricular Assist System
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorVad Percutaneous Ventricular Assist SystemDevice
The CorVad Percutaneous Ventricular Assist System provides circulatory support for patients with cardiogenic shock.
| Study group | Role | What they receive |
|---|---|---|
| CorVad Percutaneous Ventricular Assist System | Experimental | Subjects with cardiogenic shock caused by cardiomyopathy will be supported by the CorVad Percutaneous Ventricular Assist System Receives: Device: CorVad Percutaneous Ventricular Assist System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 30 days post-CorVad removal or discharge (which is longer)
14-Day Mortality Rate After CorVad Removal
Measured: 14 days post-CorVad removal
Stroke
Measured: Within 30 days post-CorVad removal
Cardiovascular-Cause Mortality
Measured: Within 30 days post-CorVad removal
Re-Hospitalization Due to Cardiovascular Reasons
Re-hospitalization for cardiovascular disease
Measured: Within 30 days post-CorVad removal
MCS-ARC Type 3, 4, 5 Bleeding
Measured: 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.
Measured: Within 30 days post-CorVad removal
Duration of Device Use
Measured: 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
Measured: During CorVad operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start12 Oct 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Core Medical Technology CO.,LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646224
- Sponsor's protocol ID
- COREMED_Corvad_CMCS
- Status last verified
- May 2024
- First submitted
- 8 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At this moment the IPD is not yet available for access and will be updated when it is ready.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06646224
- Acronym / sponsor ID
- COREMED_Corvad_CMCS
- Conditions
- Cardiogenic Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shenzhen Core Medical Technology CO.,LTD.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CorVad Percutaneous Ventricular Assist System | Experimental | Device: CorVad Percutaneous Ventricular Assist SystemSubjects with cardiogenic shock caused by cardiomyopathy will be supported by the CorVad Percutaneous Ventricular Assist System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (9 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorVad Percutaneous Ventricular Assist SystemThe CorVad Percutaneous Ventricular Assist System provides circulatory support for patients with cardiogenic shock. | Device | CorVad Percutaneous Ventricular Assist System |
Primary outcome
Survival Rate of Subjects
Time frame: Recovery: 30 days post-CorVad removal or discharge (which is longer); Bridge to Other Therapy: 30 days post-heart transplantation or LVAD implantation
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.
9 secondary outcomes
In-Hospital Mortality Rate
Time frame: 30 days post-CorVad removal or discharge (which is longer)
14-Day Mortality Rate After CorVad Removal
Time frame: 14 days post-CorVad removal
Stroke
Time frame: Within 30 days post-CorVad removal
Cardiovascular-Cause Mortality
Time frame: Within 30 days post-CorVad removal
Re-Hospitalization Due to Cardiovascular Reasons
Time frame: Within 30 days post-CorVad removal
MCS-ARC Type 3, 4, 5 Bleeding
Time frame: Within 30 days post-CorVad removal
Serious Device-Related Adverse Events
Time frame: Within 30 days post-CorVad removal
Duration of Device Use
Time frame: 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
Time frame: During CorVad operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: Yes. At this moment the IPD is not yet available for access and will be updated when it is ready.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CorVad Percutaneous Ventricular Assist System in people with Cardiogenic Shock, run by Shenzhen Core Medical Technology CO.,LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Shi (+86 13418601356, shixiaoli@coretechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Rate of Subjects (time frame: Recovery: 30 days post-CorVad removal or discharge (which is longer); Bridge to Other Therapy: 30 days post-heart transplantation or LVAD implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.