A Prospective, Multicenter,Single-arm Study of DuoCor 2 Ventricular Assist System for the Treatment of Advanced Biventricular Heart Failure
NCT07757451 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2026-08-11
Summary
The objective of this clinical investigation is to evaluate the safety and efficacy of the DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in subjects with advanced biventricular heart failure requiring circulatory support.
Each subject receiving the DuoCor 2 VAS will be evaluated at 6 months (180 days) for primary and secondary endpoints with further follow-up assessments up to 2 years.
Conditions
- Advanced Heart Failure
Interventions
- DEVICE
-
DuoCor 2 Ventricular Assist System (DuoCor 2 VAS)
Implantation of the DuoCor 2 Ventricular Assist System for mechanical circulatory support.
Sponsors & Collaborators
-
Shenzhen Core Medical Technology CO.,LTD.
lead INDUSTRY
Principal Investigators
-
Nianguo Dong · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
- 2026-10-31
- Primary Completion
- 2028-07-31
- Completion
- 2030-01-31
Countries
- China
Study Locations
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