HAART Annuloplasty Device Valve Repair Registry

Study Overview
=================
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 routine cardiovascular practice setting.

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 geometry of the aortic valve in patients with trileaflet valve morphology (HAART 300) or bicuspid valve morphology (HAART 200) with moderate to severe aortic insufficiency who are undergoing aortic valve repair due to symptoms or as part of a repair for an aortic aneurysm. The study is a multicenter registry study enrolling both retrospective and prospective participants. Investigators are cardiothoracic surgeons specializing in surgery of the aortic valve and aorta at facilities with suitable infrastructure to support collection of the registry study data. Patients who underwent or will undergo aortic valve repair using either the HAART 300 or HAART 200 Device will be enrolled. All patients known to have received the HAART 300 or HAART 200 Device at participating centers will be contacted and offered the opportunity to enroll in this registry study. Prospective participants will have evaluations prior to surgery, intraoperatively, immediately following surgery, at discharge (or within 90 days), and at 1, 3, 5, and 10 years. In addition to the follow-up clinic visits, phone contacts are scheduled at years 2,4,6, 7, 8, and 9 to maintain participant engagement as well as to ascertain if any safety events have taken place. Retrospective participants who have already received the HAART 300 or HAART 200 Device prior to study enrollment will undergo safety assessment at the time of enrollment in the study.

Official Title
-----------------
Safety and Performance of Aortic Valve Repair Using the HAART Aortic Annuloplasty Devices - A Registry Study

Conditions
-----------------
Aortic Aneurysm, Aortic Valve Insufficiency

Intervention / Treatment
-----------------
* Device: Aortic valve repair


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HAART 300<br>HAART 300 Aortic Annuloplasty Device | Device: Aortic valve repair<br>* Use of a HAART Aortic Annuloplasty Device in patients undergoing aortic valve repair surgery<br>|
| HAART 200<br>HAART 200 Aortic Annuloplasty Device | Device: Aortic valve repair<br>* Use of a HAART Aortic Annuloplasty Device in patients undergoing aortic valve repair surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from aortic valve reoperation | A reintervention for repair or replacement of the aortic valve will be considered failure for this outcome measure | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aortic valve repair, aortic valve annuloplasty