Safety and Performance Study of the Optimum Transcatheter Aortic Valve
NCT04076150 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2022-09-21
Summary
The TAVI (Thubrikar Aortic Valve, Inc.) -1 Study: Safety and Performance Study of the Optimum Transcatheter Aortic Valve- First-in-human study to assess feasibility and safety of the Optimum Aortic Valve Implant
Conditions
- Severe Aortic Stenosis
Interventions
- DEVICE
-
Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System
Treating patients with severe symptomatic aortic stenosis via transcatheter aortic valve implantation by implanting the Optimum TAV inside the native diseased valve via a the Precision Catheter. The Optimum TAV and Precision Catheter together are the Optimum TAV System.
Sponsors & Collaborators
-
KCRI
collaborator OTHER -
Thubrikar Aortic Valve, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-18
- Primary Completion
- 2022-12-18
- Completion
- 2027-05-18
Countries
- Poland
Study Locations
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