NCT04035356

HAART Annuloplasty Device Valve Repair Registry

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 183 (actual)
• Sponsor: Biostable Science & Engineering · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Insufficiency
• Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Aortic valve repair	Use of a HAART Aortic Annuloplasty Device in patients undergoing aortic valve repair surgery

Timeline

• Start date: 2020-09-22
• Primary completion: 2024-07-25
• Completion: 2024-07-25
• First posted: 2019-07-29
• Last updated: 2024-08-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study