TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease
NCT05536310 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600
Last updated 2023-01-11
Summary
To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).
Conditions
- Aortic Valve Stenosis
- Aortic Valve Regurgitation
- Aortic Valve Stenosis With Insufficiency
- Constriction, Pathologic
- Aortic Valve Disease
- Heart Valve Diseases
- Cardiovascular Diseases in Old Age
- Ventricular Outflow Obstruction
- Aortic Stenosis, Severe
Interventions
- DEVICE
-
Transcatheter Aortic Valve Implantation (TAVI)
TAVI with the JenaValve Trilogy Heart Valve System
Sponsors & Collaborators
-
JenaValve Technology, Inc.
lead INDUSTRY
Principal Investigators
-
Stephan Baldus, MD · University Hospital of Cologne Heart Center
-
Hendrik Treede, MD · Johannes Gutenberg University Mainz
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-31
- Primary Completion
- 2023-10-31
- Completion
- 2027-10-31
- FDA Device
- Yes
Countries
- Germany
Study Locations
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