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Trial record 2 of 6 for:    Prohibitin-TP01

HAART Annuloplasty Device Valve Repair Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04035356
Recruitment Status : Enrolling by invitation
First Posted : July 29, 2019
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Aortic Valve Insufficiency Aortic Aneurysm 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Safety and Performance of Aortic Valve Repair Using the HAART Aortic Annuloplasty Devices - A Registry Study
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2035
Estimated Study Completion Date : July 2035

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




Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.

  2. 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).


  3. 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

  4. All cause mortality [ Time Frame: 10 years ]
    Death due to any cause

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035356


Locations
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United States, Indiana
Franciscan Health Indianapolis
Indianapolis, Indiana, United States, 46237
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
WakeMed Raleigh Campus
Raleigh, North Carolina, United States, 27610
United States, West Virginia
West Virginia University Heart & Vascular institute
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Biostable Science & Engineering
Investigators
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Principal Investigator: J. Scott Rankin, MD West Virginia University Heart and Vascular Institute
Publications:
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Responsible Party: Biostable Science & Engineering
ClinicalTrials.gov Identifier: NCT04035356    
Other Study ID Numbers: TP-01-045
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Biostable Science & Engineering:
aortic valve repair
aortic valve annuloplasty
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Valve Insufficiency
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Heart Valve Diseases
Heart Diseases