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Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT00636987
Collaborator
(none)
297
Enrollment
17
Locations
1
Arm
107
Duration (Months)
17.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.

Condition or Disease Intervention/Treatment Phase
  • Device: Biocor and Biocor Supra valves
 N/A

Detailed Description

The clinical investigation is a multi-center, prospective, non-randomized, observational, FDA-required post-approval study designed to further evaluate the safety and effectiveness of the Biocor and Biocor Supra Valves.

Study Design

Study Type:
Interventional
Actual Enrollment :
297 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves
Study Start Date :
Apr 1, 2007
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: Implanted with Biocor or Biocor Supra Valves

Device: Biocor and Biocor Supra valves
Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Other Names:
  • Heart Valve Replacement

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events [5 Years]

      Number of participants with Adverse Events

    2. Characterize Patient NYHA Functional Classification Status [5 year]

      The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with 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. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

    3. Characterize the Hemodynamic Performance of the Valve [5 Year]

      Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg. Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Requires aortic or mitral valve replacement (heart surgery such as bypass is allowed at the same time)

    • Legal age

    • Signed informed consent prior to surgery

    • Willing to complete all follow-up requirements

    Exclusion Criteria:

    • Pregnant or nursing women

    • Already have had a valve replaced other than that for the scheduled replacement

    • Needs another valve replaced

    • Cannot return for required follow-up visits

    • Have active endocarditis

    • Acute preoperative neurological event (such as a stroke)

    • Renal dialysis

    • History of substance abuse within one year or is a prison inmate

    • Participating in another study

    • Had the Biocor or Biocor Supra valve implanted but then the device was explanted

    • Life expectancy less than five years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scripps Green Hospital/Scripps Clinic La Jolla California United States 92103
    2 USC University Hospital, Department of Cardiothoracic Surgery Los Angeles California United States 90033
    3 The Heart Group, PC Evansville Indiana United States 47710
    4 Indiana Heart Hospital Indianapolis Indiana United States 46240
    5 Maine Medical Center Portland Maine United States 04102
    6 HealthEast St. Joseph Hospital Saint Paul Minnesota United States 55102
    7 St. Luke's Hospital Kansas City Missouri United States 64111
    8 Catholic Medical Center Manchester New Hampshire United States 03102
    9 Robert Wood Johnson Medical School New Brunswick New Jersey United States 08903
    10 Valley Hospital Ridgewood New Jersey United States 07450
    11 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    12 Providence St. Vincent Medical Center Portland Oregon United States 97225
    13 Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    14 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    15 Wellmont Holston Valley Medical Center Kingsport Tennessee United States 37660
    16 Saint Thomas Hospital Nashville Tennessee United States 37205
    17 Sentara Norfolk General Hospital/Sentara Heart Hospital Norfolk Virginia United States 23507

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    • Study Director: Urban Lonn, MD, PhD, Abbott Medical Devices

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT00636987
    Other Study ID Numbers:
    • 0505
    First Posted:
    Mar 17, 2008
    Last Update Posted:
    Feb 4, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Abbott Medical Devices
    aortic valve
    mitral valve
    heart valve
    tissue valve
    bioprosthesis
    valve disorder
    valve disease
    cardiac surgery
    aortic valve regurgitation
    aortic valve stenosis
    mitral valve regurgitation
    mitral valve stenosis
    Additional relevant MeSH terms:
    Aortic Valve Stenosis
    Mitral Valve Insufficiency
    Aortic Valve Insufficiency
    Mitral Valve Stenosis
    Constriction, Pathologic

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Implanted With Biocor or Biocor Supra Valves
    Arm/Group Description Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
    Period Title: Overall Study
    STARTED 297
    COMPLETED 108
    NOT COMPLETED 189

    Baseline Characteristics

    Arm/Group Title Implanted With Biocor or Biocor Supra Valves
    Arm/Group Description Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
    Overall Participants 297
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    72.2
    (9.4)
    Sex: Female, Male (Count of Participants)
    Female
    123
    41.4%
    Male
    174
    58.6%
    Region of Enrollment (participants) [Number]
    United States
    297
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Adverse Events
    Description Number of participants with Adverse Events
    Time Frame 5 Years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Implanted With Biocor, Biocor Supra, Biocor Mitral Valves
    Arm/Group Description Biocor (aortic), Biocor Supra (aortic) and Biocor Mitral valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
    Measure Participants 297
    Mortality-valve related
    6
    2%
    Mortality-cardiac related
    14
    4.7%
    Bleed
    53
    17.8%
    Embolism
    10
    3.4%
    Endocarditis
    10
    3.4%
    Reoperation-explant
    13
    4.4%
    Structural Deterioration
    3
    1%
    Thrombosis
    1
    0.3%
    2. Primary Outcome
    Title Characterize Patient NYHA Functional Classification Status
    Description The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with 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. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.
    Time Frame 5 year

    Outcome Measure Data

    Analysis Population Description
    Number of participants that completed the visit and assessment
    Arm/Group Title Implanted With Biocor or Biocor Supra Valves
    Arm/Group Description Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
    Measure Participants 106
    NYHA I
    73
    24.6%
    NYHA II
    24
    8.1%
    NYHA III
    9
    3%
    NYHA IV
    0
    0%
    3. Primary Outcome
    Title Characterize the Hemodynamic Performance of the Valve
    Description Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg. Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.
    Time Frame 5 Year

    Outcome Measure Data

    Analysis Population Description
    Number of participants that completed the visit and assessment
    Arm/Group Title Biocor Valve Biocor Supra Valve Biocor Mitral Valve
    Arm/Group Description Biocor valves: Replacement for a diseased, damaged, malformed aortic heart valve
    Measure Participants 43 30 17
    19mm
    NA
    (NA)
    17.8
    (7.8)
    NA
    (NA)
    21mm
    20.5
    (8.1)
    12.7
    (5.9)
    NA
    (NA)
    23mm
    16.7
    (6.3)
    15.1
    (4.9)
    NA
    (NA)
    25mm
    11.3
    (5.5)
    9.0
    (2.3)
    NA
    (NA)
    27mm
    14.4
    (4)
    5.6
    (0)
    4.2
    (0.6)
    29mm
    11.3
    (7.3)
    NA
    (NA)
    3.7
    (2.3)
    31mm
    NA
    (NA)
    NA
    (NA)
    1.9
    (0.7)
    33mm
    NA
    (NA)
    NA
    (NA)
    2.0
    (0.8)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Implanted With Biocor or Biocor Supra Valves
    Arm/Group Description Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
    All Cause Mortality
    Implanted With Biocor or Biocor Supra Valves
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Implanted With Biocor or Biocor Supra Valves
    Affected / at Risk (%) # Events
    Total 91/297 (30.6%)
    Cardiac disorders
    Endocarditis 10/297 (3.4%)
    Structural Deterioration 3/297 (1%)
    Thrombosis 1/297 (0.3%)
    Nervous system disorders
    Embolism 10/297 (3.4%)
    Surgical and medical procedures
    Reoperation-Explant 13/297 (4.4%)
    Vascular disorders
    Major Bleed 50/297 (16.8%)
    Minor Bleed 4/297 (1.3%)
    Other (Not Including Serious) Adverse Events
    Implanted With Biocor or Biocor Supra Valves
    Affected / at Risk (%) # Events
    Total 0/297 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/Title Sr. Clinical Manager
    Organization St Jude Medical
    Phone 6517566803
    Email jjohnson101@sjm.com
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT00636987
    Other Study ID Numbers:
    • 0505
    First Posted:
    Mar 17, 2008
    Last Update Posted:
    Feb 4, 2019
    Last Verified:
    Jan 1, 2019