Safety and Performance of Aortic Valve Repair Using the HAART Aortic Annuloplasty Devices - A Registry Study
Status: Terminated
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
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 routine cardiovascular practice setting.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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.
Locations
United States
Indiana
Franciscan Health Indianapolis
Indianapolis
Michigan
University of Michigan Medical Center
Ann Arbor
Missouri
Missouri Baptist Medical Center
St Louis
North Carolina
Duke University
Durham
West Virginia
West Virginia University Heart & Vascular institute
Morgantown
Time Frame
Start Date: 2020-09-22
Completion Date: 2024-07-25
Participants
Target number of participants: 183
Treatments
HAART 300
HAART 300 Aortic Annuloplasty Device
HAART 200
HAART 200 Aortic Annuloplasty Device
Related Therapeutic Areas
Sponsors
Leads: Biostable Science & Engineering