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Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

Primary Purpose

Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biocor and Biocor Supra valves
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Insufficiency focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Green Hospital/Scripps Clinic
  • USC University Hospital, Department of Cardiothoracic Surgery
  • The Heart Group, PC
  • Indiana Heart Hospital
  • Maine Medical Center
  • HealthEast St. Joseph Hospital
  • St. Luke's Hospital
  • Catholic Medical Center
  • Robert Wood Johnson Medical School
  • Valley Hospital
  • Cleveland Clinic Foundation
  • Providence St. Vincent Medical Center
  • Penn State Milton S. Hershey Medical Center
  • Hospital of the University of Pennsylvania
  • Wellmont Holston Valley Medical Center
  • Saint Thomas Hospital
  • Sentara Norfolk General Hospital/Sentara Heart Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Implanted with Biocor or Biocor Supra Valves

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
Number of participants with Adverse Events
Characterize Patient NYHA Functional Classification Status
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.
Characterize the Hemodynamic Performance of the Valve
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.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2008
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00636987
Brief Title
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
Official Title
Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence, Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Stenosis, Mitral Valve Incompetence
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
297 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implanted with Biocor or Biocor Supra Valves
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Biocor and Biocor Supra valves
Other Intervention Name(s)
Heart Valve Replacement
Intervention Description
Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Number of participants with Adverse Events
Time Frame
5 Years
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urban Lonn, MD, PhD
Organizational Affiliation
Abbott Medical Devices
Official's Role
Study Director
Facility Information:
Facility Name
Scripps Green Hospital/Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
USC University Hospital, Department of Cardiothoracic Surgery
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
The Heart Group, PC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States
Facility Name
Indiana Heart Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46240
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
HealthEast St. Joseph Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Catholic Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Facility Name
Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Saint Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Sentara Norfolk General Hospital/Sentara Heart Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

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Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

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