HAART Annuloplasty Device Valve Repair Registry
Sponsored by Biostable Science & Engineering
About this trial
Last updated 2 years ago
Study ID
TP-01-045
Status
Terminated
Type
Observational
Placebo
No
Accepting
All Ages
All Sexes
Trial Timing
Ended 2 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
* 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 Criteria
* Retrospective patient that has undergone a subsequent aortic valve replacement procedure.