Clinical trial NCT04035356: HAART Annuloplasty Device Valve Repair Registry
Official title: Safety and Performance of Aortic Valve Repair Using the HAART Aortic Annuloplasty Devices - A Registry Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aortic Valve Insufficiency
Aortic Aneurysm
Keywords: aortic valve repair
aortic valve annuloplasty
Lead sponsor: Biostable Science & Engineering
Sponsor class: INDUSTRY
First posted: 2019-07-29
Enrollment: 183
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent or will undergo aortic valve repair using either the HAART 300 or HAART 200 Device at participating centers.

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.

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.

Primary outcomes:
measure: Freedom from aortic valve reoperation
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
measure: NYHA Functional Classification
timeFrame: 10 years
measure: Aortic valve regurgitation grade
timeFrame: 10 years
measure: Freedom from Cardiovascular Events
timeFrame: 10 years
measure: All cause mortality
timeFrame: 10 years
measure: Noncardiovascular serious adverse events
timeFrame: 10 years
Locations:
city: Indianapolis
country: United States
facility: Franciscan Health Indianapolis
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Morgantown
country: United States
facility: West Virginia University Heart & Vascular institute
state: West Virginia
Study officials:
affiliation: West Virginia University Heart and Vascular Institute
name: J. Scott Rankin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazzitelli D, Fischlein T, Rankin JS, Choi YH, Stamm C, Pfeiffer S, Pirk J, Detter C, Kroll J, Beyersdorf F, Griffin CD, Shrestha M, Nobauer C, Crooke PS, Schreiber C, Lange R. Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device. Eur J Cardiothorac Surg. 2016 Mar;49(3):987-93. doi: 10.1093/ejcts/ezv234. Epub 2015 Jul 8.
citation: Mazzitelli D, Pfeiffer S, Rankin JS, Fischlein T, Choi YH, Wahlers T, Nobauer C, Schreiber C, Lange R. A Regulated Trial of Bicuspid Aortic Valve Repair Supported by Geometric Ring Annuloplasty. Ann Thorac Surg. 2015 Jun;99(6):2010-6. doi: 10.1016/j.athoracsur.2015.01.050. Epub 2015 Apr 10.
citation: Rankin JS, Mazzitelli D, Fischlein T, Choi YH, Pirk J, Pfeiffer S, Wei LM, Badhwar V. Geometric Ring Annuloplasty for Aortic Valve Repair During Aortic Aneurysm Surgery: Two-Year Clinical Trial Results. Innovations (Phila). 2018 Jul/Aug;13(4):248-253. doi: 10.1097/IMI.0000000000000539.