Corheart 6 LVAS Study
NCT05876000 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2026-01-08
Summary
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.
Conditions
- Refractory Heart Failure
Interventions
- DEVICE
-
Corheart 6 Left Ventricular Assist System
Implantation of left ventricular assist device for mechanical circulatory support
Sponsors & Collaborators
-
Shenzhen Core Medical Technology CO.,LTD.
lead INDUSTRY
Principal Investigators
-
Evgenij V Potapov · German Heart Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-14
- Primary Completion
- 2026-12-30
- Completion
- 2031-06-30
Countries
- Austria
- Germany
- Italy
Study Locations
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