Corheart 6 LVAS Study

Recruiting N/A Interventional Study
Refractory Heart Failure
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
53 (estimated)
Sponsor
Shenzhen Core Medical Technology CO.,LTD. · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 1\. Age ≥ 18 years and ≤ 75 years * 2\. The patient has signed an Informed Consent Form * 3\. Body Surface Area (BSA) ≥ 1.2 m\^2 * 4\. New York Heart Association (NYHA) Class IV * 5\. Left Ventricular Ejection Fraction (LVEF) ≤ 25% * 6\. Despite the optimal medical management …
Contacts

Xiaoli Shi

+86 13418601356

shixiaoli@coretechmed.com

CONTACT