Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
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|ClinicalTrials.gov Identifier: NCT00636987|
Recruitment Status : Completed
First Posted : March 17, 2008
Results First Posted : June 2, 2017
Last Update Posted : February 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Insufficiency Aortic Valve Regurgitation Aortic Valve Stenosis Aortic Valve Incompetence Mitral Valve Insufficiency Mitral Valve Regurgitation Mitral Valve Stenosis Mitral Valve Incompetence||Device: Biocor and Biocor Supra valves||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||297 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||March 2016|
|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 Name: Heart Valve Replacement
- Number of Participants With Adverse Events [ Time Frame: 5 Years ]Number of participants with Adverse Events
- Characterize Patient NYHA Functional Classification Status [ Time Frame: 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.
- Characterize the Hemodynamic Performance of the Valve [ Time Frame: 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.
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): NCT00636987
|Study Director:||Urban Lonn, MD, PhD||Abbott Medical Devices|