Health TrialsbyHealthPanel

Corheart 6 LVAS Clinical Investigation

ConditionAdvanced Left Ventricular Heart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen Core Medical Technology CO.,LTD.

About this trial

To evaluate the safety and effectiveness of the Corheart 6 left ventricular assist system in providing mechanical support for blood circulation in patients with advanced left ventricular heart failure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years and ≤ 75 years

The patient has signed an Informed Consent Form

Body Surface Area (BSA) ≥ 1.2 m2

New York Heart Association (NYHA) Class IV

Disqualifiers

Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)

Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.

Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.

Platelet count < 100,000 x 103/L (< 100,000/ml).

Trial design

Design model

Single group

Treatments tested in this trial

  • Corheart 6 LVAS

    Device

    Implantation of left ventricular assist device for mechanical circulatory support

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Corheart 6 LVASExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite Survival Rate without Disabling Stroke

Composite survival is defined as meeting one of the following conditions: * Surviving with the original device for 6 months after surgery without disabling stroke (mRS score \> 3 at 3 months after stroke), and without reoperation (replacement or removal) due to device problems; * Bridging to heart transplantation within 6 months after implantation; * Removal of the original device due to recovery of cardiac function within 6 months after implantation.

Time frame
6 months after device implantation

Secondary outcomes

1

Composite Survival Rate without Disabling Stroke

Time frame
24 months after device implantation
2

Composite Survival Rate

5-year composite survival rate after implantation

Time frame
5 years after device implantation
3

Bridge Heart Transplantation Rate

Time frame
6 months, 12 months, 24 months, 5 years after surgery
4

Device Removal Rate

Device removal rate due to recovery of cardiac function

Time frame
6 months, 12 months, 24 months, 5 years after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Core Medical Technology CO.,LTD.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: