An interventional study of CorVad Percutaneous Ventricular Assist System in Cardiogenic Shock, sponsored by Shenzhen Core Medical Technology CO.,LTD.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Shenzhen Core Medical Technology CO.,LTD. · Not applicable, Interventional, and Treatment
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Among 20 studies in Shock, Cardiogenic with a site in China — 18 open to participants now, 18 under way, none of them phase 3. Shock, Cardiogenic · China.
Among the 20 studies in Shock, Cardiogenic with a site in China, this one is the 12th largest by planned enrollment of the 14 interventional ones that give a count, is the only one that started in 2024, is one of 12 with no phase, reaches primary completion later than 3 of the 17 other live ones, and was the 12th registered.
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
Browse Shock, Cardiogenic studies →18 of the 20 studies in Shock, Cardiogenic with a site in China are open now. Recruiting first, the newest first:
ForQaly Medical (Shanghai) Co., Ltd · Sites in China
Ages 18–80
China National Center for Cardiovascular Diseases · Sites in China
Ages 18+
Renmin Hospital of Wuhan University · Sites in China
Ages 18+
Xiaotong Hou · Sites in China
Ages 18+
Fujian Medical University · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 102 Shock, Cardiogenic studies recruiting now, 70 (69%) set no upper age limit and 9 (9%) stop at 75 or younger; 11 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is below the median of 80 across 133 interventional studies indexed under Shock, Cardiogenic.
Median enrollment 82 across the 14 interventional studies, 517 across the 6 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.
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3 of 20 have an industry lead sponsor. The 10 most frequent:
Shenzhen Core Medical Technology CO.,LTD. is the lead sponsor of 12 studies on the registry; 8 are open to participants now.
Shenzhen Core Medical Technology CO.,LTD. has 2 studies filed under Shock, Cardiogenic — fewer than ten, so there is no comparison to draw.
3 of the studies in Shock, Cardiogenic with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06862700Xiaotong HouEffect of Reduced Vasopressors on Mortality in ECMO-supported Cardiogenic Shock Patients | 2027-01-01 |
| NCT07380659Second Affiliated Hospital, School of Medicine, Zhejiang UniversitySafety and Efficacy of FAP iCDC in Acute Myocardial Infarction With Cardiogenic Shock | 2027-01-30 |
| NCT07560085ForQaly Medical (Shanghai) Co., LtdCatheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock | 2027-06 |
Add all 3 to your calendar (.ics) → With an account.
Among the 20 studies in Shock, Cardiogenic with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Occurrence of cardiogenic shock under adequate blood volume, which must meet one of the following conditions:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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
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
Re-hospitalization for cardiovascular disease
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
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.
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
Device malfunction is defined as a flow rate of less than 1L/min at S5 or higher speed level lasting more than 5 minutes
Time frame: During CorVad operation
Plan to share: Yes — At this moment the IPD is not yet available for access and will be updated when it is ready.
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for May 2025, 7 months later.
Of 53 interventional studies with no phase under Shock, Cardiogenic, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 55. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
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