Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
NCT05082454 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 108
Last updated 2025-02-05
Summary
The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.
Conditions
- Aortic Valve Disease
Interventions
- DEVICE
-
Open repair
Open repair of the aortic heart valve and ascending thoracic aorta
Sponsors & Collaborators
-
JOTEC GmbH
lead INDUSTRY
Principal Investigators
-
Davide Pacini, Prof. Dr. · Policlinico S. Orsola-Malpighi
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-20
- Primary Completion
- 2024-02-06
- Completion
- 2029-03-31
- FDA Device
- Yes
Countries
- United States
- Germany
- Italy
- Spain
- United Kingdom
Study Locations
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