Status:
TERMINATED
HAART Annuloplasty Device Valve Repair Registry
Lead Sponsor:
Biostable Science & Engineering
Conditions:
Aortic Valve Insufficiency
Aortic Aneurysm
Eligibility:
All Genders
Brief Summary
Multicenter US registry study to assess procedure success and long-term (10-year) performance of the HAART 200 and HAART 300 Aortic Annuloplasty Devices when used during aortic valve repair in a routi...
Detailed Description
The HAART Aortic Annuloplasty Devices are three-dimensional annuloplasty rings designed to be implanted intra-annularly in the aortic valve to correct annular dilatation and/or maintain annular geomet...
Eligibility Criteria
Inclusion
- The patient underwent or is undergoing aortic valve repair using either the HAART 300 or HAART 200 Aortic Annuloplasty Device in accordance with the Instructions for Use.
- The patient has reviewed and signed the written informed consent form.
- The patient agrees to return for all follow-up evaluations for the duration of the study.
Exclusion
- Retrospective patient that has undergone a subsequent aortic valve replacement procedure.
Key Trial Info
Start Date :
September 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 25 2024
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT04035356
Start Date
September 22 2020
End Date
July 25 2024
Last Update
August 9 2024
Active Locations (5)
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1
Franciscan Health Indianapolis
Indianapolis, Indiana, United States, 46237
2
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
3
Missouri Baptist Medical Center
St Louis, Missouri, United States, 63131
4
Duke University
Durham, North Carolina, United States, 27705