HAART Annuloplasty Device Valve Repair Registry

Terminated

• Conditions: Aortic Valve Insufficiency; Aortic Aneurysm
• Interventions: Device: Aortic valve repair

• Registration Number: NCT04035356
• Lead Sponsor: Biostable Science & Engineering

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.

Study Timeline

• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Study Start: 2020-09-22
• Primary Completion: 2024-07-25
• Study Completion: 2024-07-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 183

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HAART 300	Aortic valve repair	HAART 300 Aortic Annuloplasty Device
HAART 200	Aortic valve repair	HAART 200 Aortic Annuloplasty Device

Primary Outcome Measures

Name	Time	Method
Freedom from aortic valve reoperation	10 years	A reintervention for repair or replacement of the aortic valve will be considered failure for this outcome measure

Trial Locations

Locations (5)

West Virginia University Heart & Vascular institute; 🇺🇸 Morgantown, West Virginia, United States

Missouri Baptist Medical Center; 🇺🇸 Saint Louis, Missouri, United States

Franciscan Health Indianapolis; 🇺🇸 Indianapolis, Indiana, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States