Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation
NCT03025971 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107
Last updated 2024-09-19
Summary
A prospective, multicenter, nonrandomized, single-arm, clinical study.
Conditions
- Aortic Valve Disease
Interventions
- DEVICE
-
J-Valve Transcatheter Aortic valve replacement
Transapical Transcatheter Aortic Valve Replacement
Sponsors & Collaborators
-
JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
lead INDUSTRY
Principal Investigators
-
Ji Zhang, MD · CEO, President
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2016-04-30
- Completion
- 2020-04-30
Countries
- China
Study Locations
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