Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves
1 other identifier
interventional
297
1 country
17
Brief Summary
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2007
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 10, 2008
CompletedFirst Posted
Study publicly available on registry
March 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
June 2, 2017
CompletedFebruary 4, 2019
January 1, 2019
8.5 years
March 10, 2008
October 14, 2016
January 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants With Adverse Events
Number of participants with Adverse Events
5 Years
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.
5 year
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.
5 Year
Study Arms (1)
Implanted with Biocor or Biocor Supra Valves
OTHERInterventions
Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Scripps Green Hospital/Scripps Clinic
La Jolla, California, 92103, United States
USC University Hospital, Department of Cardiothoracic Surgery
Los Angeles, California, 90033, United States
The Heart Group, PC
Evansville, Indiana, 47710, United States
Indiana Heart Hospital
Indianapolis, Indiana, 46240, United States
Maine Medical Center
Portland, Maine, 04102, United States
HealthEast St. Joseph Hospital
Saint Paul, Minnesota, 55102, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Catholic Medical Center
Manchester, New Hampshire, 03102, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903, United States
Valley Hospital
Ridgewood, New Jersey, 07450, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37660, United States
Saint Thomas Hospital
Nashville, Tennessee, 37205, United States
Sentara Norfolk General Hospital/Sentara Heart Hospital
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Clinical Manager
- Organization
- St Jude Medical
Study Officials
- STUDY DIRECTOR
Urban Lonn, MD, PhD
Abbott Medical Devices
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2008
First Posted
March 17, 2008
Study Start
April 1, 2007
Primary Completion
October 1, 2015
Study Completion
March 1, 2016
Last Updated
February 4, 2019
Results First Posted
June 2, 2017
Record last verified: 2019-01