Aortic Valve Stenosis Clinical Trial
Official title:
Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves
NCT number | NCT00636987 |
Other study ID # | 0505 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2007 |
Est. completion date | March 2016 |
Verified date | January 2019 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
Status | Completed |
Enrollment | 297 |
Est. completion date | March 2016 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | The Heart Group, PC | Evansville | Indiana |
United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Indiana Heart Hospital | Indianapolis | Indiana |
United States | St. Luke's Hospital | Kansas City | Missouri |
United States | Wellmont Holston Valley Medical Center | Kingsport | Tennessee |
United States | Scripps Green Hospital/Scripps Clinic | La Jolla | California |
United States | USC University Hospital, Department of Cardiothoracic Surgery | Los Angeles | California |
United States | Catholic Medical Center | Manchester | New Hampshire |
United States | Saint Thomas Hospital | Nashville | Tennessee |
United States | Robert Wood Johnson Medical School | New Brunswick | New Jersey |
United States | Sentara Norfolk General Hospital/Sentara Heart Hospital | Norfolk | Virginia |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Maine Medical Center | Portland | Maine |
United States | Providence St. Vincent Medical Center | Portland | Oregon |
United States | Valley Hospital | Ridgewood | New Jersey |
United States | HealthEast St. Joseph Hospital | Saint Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Adverse Events | Number of participants with Adverse Events | 5 Years | |
Primary | 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 | |
Primary | 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 |
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