Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
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| ClinicalTrials.gov Identifier: NCT00636987 |
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Recruitment Status :
Completed
First Posted : March 17, 2008
Results First Posted : June 2, 2017
Last Update Posted : February 4, 2019
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| 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 |
| 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 : | April 2007 |
| Actual Primary Completion Date : | October 2015 |
| Actual Study Completion Date : | March 2016 |
| Arm | Intervention/treatment |
|---|---|
| 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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
Show 17 study locations
| Study Director: | Urban Lonn, MD, PhD | Abbott Medical Devices |
| Responsible Party: | Abbott Medical Devices |
| ClinicalTrials.gov Identifier: | NCT00636987 |
| Other Study ID Numbers: |
0505 |
| First Posted: | March 17, 2008 Key Record Dates |
| Results First Posted: | June 2, 2017 |
| Last Update Posted: | February 4, 2019 |
| Last Verified: | January 2019 |
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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 |
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Aortic Valve Stenosis Mitral Valve Insufficiency Aortic Valve Insufficiency Mitral Valve Stenosis Constriction, Pathologic Pathological Conditions, Anatomical |
Aortic Valve Disease Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |