Corheart 6 LVAS Clinical Investigation
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
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
Treatments tested in this trial
- Corheart 6 LVAS
Treatment groups
100 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov