Corheart 6 LVAS Study

ConditionRefractory Heart Failure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShenzhen Core Medical Technology CO.,LTD.

About this trial

The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation.

The secondary objective is to assess the long-term safety and effectiveness of Corheart 6 LVAS treatment.

Eligibility criteria

Qualifiers

1. Age ≥ 18 years and ≤ 75 years

2. The patient has signed an Informed Consent Form

3. Body Surface Area (BSA) ≥ 1.2 m²

4. New York Heart Association (NYHA) Class IV

Disqualifiers

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

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

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

4. Platelet count < 100,000 x 10^3/L (< 100,000/ml).