Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
NCT03788590 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133
Last updated 2019-01-08
Summary
The purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality in severe aortic stenosis or insufficiency patients who are high risk or ineligible for aortic valve replacement.
Conditions
- Severe Aortic Stenosis
- Aortic Regurgitation
Interventions
- DEVICE
-
Jenscare TAVI
Jenscare TAVI and delivery system will implant a percutaneous bioprosthesis value, which is positioned in the native aortic valve, plays a role to control blood flow, and help your heart to work better. It may also shorten your recovery time to getting back to everyday activities.
Sponsors & Collaborators
-
Ningbo Jenscare Biotechnology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Peng Cao, Doctor · Ningbo Jenscare Biotechnology Co., Ltd.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-23
- Primary Completion
- 2021-11-23
- Completion
- 2021-12-30
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