HAART Annuloplasty Device Valve Repair Registry

February 6, 2023 updated by: Biostable Science & Engineering

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

Enrolling by invitation

Conditions

Intervention / Treatment

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 (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 10 years
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
Time Frame: 10 years

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
Time Frame: 10 years

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
Time Frame: 10 years

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
Time Frame: 10 years
Death due to any cause
10 years
Noncardiovascular serious adverse events
Time Frame: 10 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Biostable Science & Engineering

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 22, 2020

Primary Completion (ANTICIPATED)

July 1, 2035

Study Completion (ANTICIPATED)

July 1, 2035

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)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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