HAART Annuloplasty Device Valve Repair Registry

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

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.

Study Overview

• Status: Terminated
• Conditions: Aortic Valve Insufficiency; Aortic Aneurysm
• Intervention / Treatment: Device: Aortic valve repair

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 Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Health Indianapolis
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Heart & Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HAART 300; HAART 300 Aortic Annuloplasty Device	Device: Aortic valve repair; Use of a HAART Aortic Annuloplasty Device in patients undergoing aortic valve repair surgery
HAART 200; HAART 200 Aortic Annuloplasty Device	Device: Aortic valve repair; Use of a HAART Aortic Annuloplasty Device in patients undergoing aortic valve repair surgery

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
NYHA Functional Classification	New York Hospital Association (NYHA) class: Class I: cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.; Class II: cardiac disease resulting in slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.; Class III: cardiac disease resulting in marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.; Class IV: cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.	10 years
Aortic valve regurgitation grade	The severity of aortic valve regurgitation expressed as the aortic regurgitation (AR) Grade (or Aortic insufficiency (AI) Grade). The grades are defined by the American Society of Echocardiography guidelines based on regurgitant volume (RVol), regurgitant fraction (RF), and effective regurgitant orifice area (EROA), and expressed as: 0 (None/trace) I (Mild: RVol <30 mL, RF <30%, EROA <0.1 cm**2) II (Mild-Moderate: RVol 30-44 mL, RF 30-39%, EROA 0.1-0.19 cm**2) III (Moderate-Severe: RVol 45-59 mL, RF 40-49%, EROA 0.20.29 cm**2) IV (Severe: RVol ≥60 mL, RF ≥50%, EROA ≥0.3 cm**2).	10 years
Freedom from Cardiovascular Events	Occurrence of any of the following events will be considered failure on this outcome measure.; Cardiac-related death; Aortic valve reintervention/reoperation; Major bleeding event; Structural valve deterioration; Nonstructural dysfunction; Operated valve endocarditis; Valve thrombosis; New permanent pacemaker or defibrillator within 14 days after the valve intervention; Embolism	10 years
All cause mortality	Death due to any cause	10 years
Noncardiovascular serious adverse events	Adverse events not of cardiovascular nature that led to death, resulted in a life-threatening illness or injury, resulted in hospitalization, or resulted in persistent or significant disability/incapacity.	10 years

Collaborators and Investigators

• Sponsor: Biostable Science & Engineering
• Investigators: Principal Investigator: J. Scott Rankin, MD, West Virginia University Heart and Vascular Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Actual): July 25, 2024
• Study Completion (Actual): July 25, 2024

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: aortic valve annuloplasty; aortic valve repair
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aneurysm; Aortic Diseases; Aortic Valve Insufficiency; Aortic Aneurysm
• Other Study ID Numbers: TP-01-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes