A Prospective, Multicenter Study to Evaluate the JensClip Transcatheter Valve Repair System
NCT05417945 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2022-06-14
Summary
The clinical trial study is designed as a prospective, multicenter, single-group target value clinical study to evaluate the safety and efficacy of the clinical investigational product and to evaluate its performance using the above clinical trial primary endpoint and secondary endpoint indicators.
Conditions
- Degenerative Mitral Valve Disease
- Mitral Valve Regurgitation
Interventions
- DEVICE
-
JensClip transcatheter valve repair system
Transcatheter mitral valve repair system is derived from the "Edge-to-Edge" technique in traditional surgery. The principle is roughly to clamp the midpoint of the anterior leaflet and the midpoint of the posterior leaflet of the mitral valve to form a double-hole inflow channel and then improve the regurgitation.
Sponsors & Collaborators
-
Jenscare Scientific
lead INDUSTRY
Principal Investigators
-
Shengshou Hu · FUWAI YUNAN CARDIOVASCULAR HOSPITAL
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-30
- Primary Completion
- 2024-05-31
- Completion
- 2024-12-31
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