HAART Annuloplasty Device Valve Repair Registry

NCT04035356 | Terminated FDA Device

• 1 other identifier: TP-01-045
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 5

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.

Conditions

Aortic Valve Insufficiency; Aortic Aneurysm

Keywords

aortic valve repair; aortic valve annuloplasty

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (5)

• NYHA Functional Classification

  10 years

• Aortic valve regurgitation grade

  10 years

• Freedom from Cardiovascular Events

  10 years

Study Arms (2)

HAART 300

HAART 300 Aortic Annuloplasty Device

Device: Aortic valve repair

HAART 200

HAART 200 Aortic Annuloplasty Device

Device: Aortic valve repair

Interventions

Aortic valve repair DEVICE

Use of a HAART Aortic Annuloplasty Device in patients undergoing aortic valve repair surgery

HAART 200; HAART 300

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Retrospective patient that has undergone a subsequent aortic valve replacement procedure.

Sponsors & Collaborators

• Biostable Science & Engineering: lead

Study Sites (5)

Franciscan Health Indianapolis

Indianapolis, Indiana, 46237, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

West Virginia University Heart & Vascular institute

Morgantown, West Virginia, 26506, United States

Location

Related Publications (3)

• 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.

  PMID: 26156945 BACKGROUND

• 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.

  PMID: 25865762 BACKGROUND

• 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.

  PMID: 30138245 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Insufficiency; Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Aneurysm; Vascular Diseases; Aortic Diseases

Study Officials

• J. Scott Rankin, MD

  West Virginia University Heart and Vascular Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 29, 2019
• Study Start: September 22, 2020
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

US (5)