Aortic Valve Incompetence, Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Mitral Valve Incompetence, Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Stenosis
Conditions
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
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.
Interventions
DEVICEBiocor and Biocor Supra valves
Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 5 Years | Number of participants with Adverse Events |
| Characterize Patient NYHA Functional Classification Status | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Implanted With Biocor or Biocor Supra Valves Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve | 297 |
| Total | 297 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 5 year visit window not complete | 69 |
| Overall Study | Death | 44 |
| Overall Study | Explanted | 13 |
| Overall Study | Lost to Follow-up | 63 |
Baseline characteristics
| Characteristic | Implanted With Biocor or Biocor Supra Valves |
|---|---|
| Age, Continuous | 72.2 years STANDARD_DEVIATION 9.4 |
| Region of Enrollment United States | 297 participants |
| Sex: Female, Male Female | 123 Participants |
| Sex: Female, Male Male | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 297 |
| serious Total, serious adverse events | 91 / 297 |
Outcome results
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.
Time frame: 5 year
Population: Number of participants that completed the visit and assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Characterize Patient NYHA Functional Classification Status | NYHA I | 73 participants |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Characterize Patient NYHA Functional Classification Status | NYHA II | 24 participants |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Characterize Patient NYHA Functional Classification Status | NYHA III | 9 participants |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Characterize Patient NYHA Functional Classification Status | NYHA IV | 0 participants |
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.
Time frame: 5 Year
Population: Number of participants that completed the visit and assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Characterize the Hemodynamic Performance of the Valve | 33mm | NA mmHg | — |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Characterize the Hemodynamic Performance of the Valve | 29mm | 11.3 mmHg | Standard Deviation 7.3 |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Characterize the Hemodynamic Performance of the Valve | 25mm | 11.3 mmHg | Standard Deviation 5.5 |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Characterize the Hemodynamic Performance of the Valve | 27mm | 14.4 mmHg | Standard Deviation 4 |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Characterize the Hemodynamic Performance of the Valve | 21mm | 20.5 mmHg | Standard Deviation 8.1 |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Characterize the Hemodynamic Performance of the Valve | 19mm | NA mmHg | — |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Characterize the Hemodynamic Performance of the Valve | 31mm | NA mmHg | — |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Characterize the Hemodynamic Performance of the Valve | 23mm | 16.7 mmHg | Standard Deviation 6.3 |
| Biocor Supra Valve | Characterize the Hemodynamic Performance of the Valve | 25mm | 9.0 mmHg | Standard Deviation 2.3 |
| Biocor Supra Valve | Characterize the Hemodynamic Performance of the Valve | 19mm | 17.8 mmHg | Standard Deviation 7.8 |
| Biocor Supra Valve | Characterize the Hemodynamic Performance of the Valve | 21mm | 12.7 mmHg | Standard Deviation 5.9 |
| Biocor Supra Valve | Characterize the Hemodynamic Performance of the Valve | 23mm | 15.1 mmHg | Standard Deviation 4.9 |
| Biocor Supra Valve | Characterize the Hemodynamic Performance of the Valve | 27mm | 5.6 mmHg | Standard Deviation 0 |
| Biocor Supra Valve | Characterize the Hemodynamic Performance of the Valve | 29mm | NA mmHg | — |
| Biocor Supra Valve | Characterize the Hemodynamic Performance of the Valve | 31mm | NA mmHg | — |
| Biocor Supra Valve | Characterize the Hemodynamic Performance of the Valve | 33mm | NA mmHg | — |
| Biocor Mitral Valve | Characterize the Hemodynamic Performance of the Valve | 19mm | NA mmHg | — |
| Biocor Mitral Valve | Characterize the Hemodynamic Performance of the Valve | 29mm | 3.7 mmHg | Standard Deviation 2.3 |
| Biocor Mitral Valve | Characterize the Hemodynamic Performance of the Valve | 21mm | NA mmHg | — |
| Biocor Mitral Valve | Characterize the Hemodynamic Performance of the Valve | 33mm | 2.0 mmHg | Standard Deviation 0.8 |
| Biocor Mitral Valve | Characterize the Hemodynamic Performance of the Valve | 25mm | NA mmHg | — |
| Biocor Mitral Valve | Characterize the Hemodynamic Performance of the Valve | 31mm | 1.9 mmHg | Standard Deviation 0.7 |
| Biocor Mitral Valve | Characterize the Hemodynamic Performance of the Valve | 27mm | 4.2 mmHg | Standard Deviation 0.6 |
| Biocor Mitral Valve | Characterize the Hemodynamic Performance of the Valve | 23mm | NA mmHg | — |
Primary
Number of Participants With Adverse Events
Number of participants with Adverse Events
Time frame: 5 Years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Number of Participants With Adverse Events | Mortality-valve related | 6 participants |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Number of Participants With Adverse Events | Mortality-cardiac related | 14 participants |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Number of Participants With Adverse Events | Bleed | 53 participants |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Number of Participants With Adverse Events | Endocarditis | 10 participants |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Number of Participants With Adverse Events | Reoperation-explant | 13 participants |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Number of Participants With Adverse Events | Structural Deterioration | 3 participants |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Number of Participants With Adverse Events | Thrombosis | 1 participants |
| Implanted With Biocor, Biocor Supra, Biocor Mitral Valves | Number of Participants With Adverse Events | Embolism | 10 participants |