Heart Valve Diseases
Conditions
Keywords
Diseased Heart Valve, Replacement, Aortic
Brief summary
This is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing isolated aortic valve replacement with or without concomitant procedures. The Enable Aortic Valve is an equine pericardial stented bioprosthesis.
Detailed description
The ATS 3f Enable Aortic Bioprosthesis is intended for those patients whose prognosis without surgical replacement of the diseased natural valve is unacceptably poor in terms of survival and/or quality of life in the opinion of the attending physicians. For these patients, there are a number of widely accepted prosthetic heart valves in use.
Interventions
DEVICEATS 3f Enable Aortic Bioprosthesis Model 6000
Replacement Aortic Heart Valve
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient requires isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve repair. (The three remaining valves must be of native tissue). * The patient is geographically stable and willing to return to the implant site for follow-up visits. * The patient has been adequately informed of risks and requirements and consent to his/her participation in the clinical study. * If this patient is female and of childbearing potential, patient has a negative pregnancy test within seven (7) days prior to the study procedure.
Exclusion criteria
* The patient requires replacement of two or more valves. * The patient is \< 20 years of age. * The patient has a non-cardiac major or progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 24 months. * The patient is an intravenous drug and/or alcohol abuser. * The patient presents with active endocarditis or other systemic infection. * The patient has had previous valve replacement surgery, including previous implant and then explant of the ATS 3f Enable Aortic Bioprosthesis (Model 6000) or placement of a rigid annuloplasty ring in the mitral position. * The patient is participating in concomitant research studies of investigational products. * The patient presents with dilatation of the ascending aorta, Marfan Syndrome, Ehlers-Danlos syndrome, cystic medial degeneration, or other condition causing the ascending aorta to be irregular in geometry or physiology as seen via preoperative imaging. * The patient has chronic renal failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thromboembolism/Thrombosis | Five Years | Valve related thromboembolism and valvular thrombosis. Thrombosis was defined as any thrombus attached to or near the study valve that interfered with valve function in the absence of infection. The results are reported as linearized rate (percentage of participants per patient-year) |
| Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major) | Five Years | Any episode of internal or external bleeding in subjects receiving anticoagulant and/or antiaggregant therapy. Hemorrhage/Bleeding (No Anticoagulant/Antiaggregant): Any episode of internal or external bleeding in subjects not receiving anticoagulant and/or antiaggregant therapy. The results are reported as linearized rate (percentage of participants per patient-year). |
| Paravalvular Leaks (All and Major) | Five Years | Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis (between the sewing ring and native annulus). Major Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis, i.e. between the sewing ring and native annulus that requires surgical intervention. The results are reported as linearized rate (percentage of participants per patient-year). |
| Endocarditis | Five Years | Endocarditis was defined in the protocol as any infection involving the study valve. Any structural/non-structural valvular dysfunction, thrombosis, or embolic event associated with study valve endocarditis was captured as endocarditis only. The results are reported as linearized rate (percentage of participants per patient-year). |
| Hemolysis | Five Years | Blood data analysis was performed in order to identify whether particular complications and serious adverse events such as hemolysis occurred. Hemolysis in subjects with tissue valves - as evidenced by increased serum lactate dehydrogenase concentrations, decreased serum haptoglobin concentration, erythrocytopenia and reticulocytosis - is usually associated with paravalvular leakage or infection. |
| Structural Valve Deterioration | Five Years | Structural deterioration was defined as any change in the study valve function which resulted from an intrinsic abnormality that caused stenosis or regurgitation. There were no cases of structural deterioration reported for the study. The results are reported as linearized rate (percentage of participants per patient-year). |
| Non-Structural Dysfunction | Five Years | Any abnormality resulting in stenosis or regurgitation at the operated valve that is not intrinsic to the valve itself. Non-structural dysfunction refers to non-structural problems that result in dysfunction of an operated valve exclusive of thrombosis and infection diagnosed by reoperation, autopsy, or clinical investigation. The results are reported as linearized rate (percentage of participants per patient-year). |
| Re-operation, Explant, Repair | Five Years | Reoperation was defined in the protocol as any operation to repair, alter, or replace the study valve. Included is reoperation for repair of paravalvular leak and explant. The results are reported as linearized rate (percentage of participants per patient-year). |
| Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Five Years | New York Heart Association (NYHA) classification to asses improvement of the cardiac status, Hemodynamic Performance analysis based on Doppler echocardiographic studies. Class I: Patients with cardiac disease but without limitations of ordinary activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity results in fatigue, palpitations or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest. If any physical activity is undertaken discomfort is increased. |
| Hemodynamic | Five Years | Mean and peak pressure gradients from discharge through 5 years follow up. The gradient represents the difference in blood pressure across the valve. |
| Hemodynamics - Effective Orifice Area | Five Years | Effective orifice area (EOA) data. The effective orifice area is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve. |
| Hemodynamics - Effective Orifice Area Index | Five Years | The effective orifice area index is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve. |
Countries
Austria, Germany, Poland, Switzerland, United Kingdom
Participant flow
Pre-assignment details
Patients who required an aortic valve replacement were considered for this study if they met study preoperative selection criteria. Of 173 subjects enrolled, a cohort of 148 subjects was implanted and left the operating room with the study valve. Only subjects who left the operating room with the device implanted were included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Aortic Valve Replacement 3f Enable Aortic Bioprosthesis Model 6000 | 148 |
| Total | 148 |
Baseline characteristics
| Characteristic | Aortic Valve Replacement |
|---|---|
| Age, Continuous | 76.0 years STANDARD_DEVIATION 5.6 |
| Region of Enrollment Austria | 6 participants |
| Region of Enrollment Germany | 67 participants |
| Region of Enrollment Poland | 31 participants |
| Region of Enrollment Switzerland | 38 participants |
| Region of Enrollment United Kingdom | 6 participants |
| Sex: Female, Male Female | 91 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 148 |
| serious Total, serious adverse events | 39 / 148 |
Outcome results
Primary
Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance
New York Heart Association (NYHA) classification to asses improvement of the cardiac status, Hemodynamic Performance analysis based on Doppler echocardiographic studies. Class I: Patients with cardiac disease but without limitations of ordinary activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity results in fatigue, palpitations or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest. If any physical activity is undertaken discomfort is increased.
Time frame: Five Years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class I | 9 participants |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class III | 92 participants |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class II | 38 participants |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class IV | 3 participants |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Unknown | 6 participants |
| NYHA Class 3-6 Months | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class III | 4 participants |
| NYHA Class 3-6 Months | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class I | 47 participants |
| NYHA Class 3-6 Months | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class IV | 0 participants |
| NYHA Class 3-6 Months | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Unknown | 7 participants |
| NYHA Class 3-6 Months | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class II | 61 participants |
| NYHA Class 11-14 Months | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Unknown | 1 participants |
| NYHA Class 11-14 Months | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class IV | 0 participants |
| NYHA Class 11-14 Months | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class III | 4 participants |
| NYHA Class 11-14 Months | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class I | 51 participants |
| NYHA Class 11-14 Months | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class II | 53 participants |
| NYHA Class 2 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class II | 48 participants |
| NYHA Class 2 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class IV | 0 participants |
| NYHA Class 2 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Unknown | 0 participants |
| NYHA Class 2 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class III | 4 participants |
| NYHA Class 2 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class I | 41 participants |
| NYHA Class 3 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class II | 29 participants |
| NYHA Class 3 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Unknown | 0 participants |
| NYHA Class 3 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class I | 37 participants |
| NYHA Class 3 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class III | 5 participants |
| NYHA Class 3 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class IV | 0 participants |
| NYHA Class 4 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class IV | 0 participants |
| NYHA Class 4 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class I | 10 participants |
| NYHA Class 4 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class II | 19 participants |
| NYHA Class 4 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class III | 3 participants |
| NYHA Class 4 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Unknown | 0 participants |
| NYHA Class 5 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class IV | 0 participants |
| NYHA Class 5 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Unknown | 0 participants |
| NYHA Class 5 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class I | 1 participants |
| NYHA Class 5 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class II | 2 participants |
| NYHA Class 5 Year | Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance | Class III | 0 participants |
Primary
Endocarditis
Endocarditis was defined in the protocol as any infection involving the study valve. Any structural/non-structural valvular dysfunction, thrombosis, or embolic event associated with study valve endocarditis was captured as endocarditis only. The results are reported as linearized rate (percentage of participants per patient-year).
Time frame: Five Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Endocarditis | 0.9 percentage of participants/patient-year |
Primary
Hemodynamic
Mean and peak pressure gradients from discharge through 5 years follow up. The gradient represents the difference in blood pressure across the valve.
Time frame: Five Years
Population: At discharge, gradient data was collected of 103 subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Hemodynamic | Mean Gradient | 10.28 mmHg | Standard Deviation 4.37 |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Hemodynamic | Peak Gradient | 20.38 mmHg | Standard Deviation 8.4 |
| NYHA Class 3-6 Months | Hemodynamic | Mean Gradient | 9.02 mmHg | Standard Deviation 3.7 |
| NYHA Class 3-6 Months | Hemodynamic | Peak Gradient | 18.15 mmHg | Standard Deviation 7.17 |
| NYHA Class 11-14 Months | Hemodynamic | Mean Gradient | 8.59 mmHg | Standard Deviation 3.19 |
| NYHA Class 11-14 Months | Hemodynamic | Peak Gradient | 16.58 mmHg | Standard Deviation 6.16 |
| NYHA Class 2 Year | Hemodynamic | Mean Gradient | 8.52 mmHg | Standard Deviation 3.39 |
| NYHA Class 2 Year | Hemodynamic | Peak Gradient | 16.65 mmHg | Standard Deviation 6.89 |
| NYHA Class 3 Year | Hemodynamic | Mean Gradient | 8.77 mmHg | Standard Deviation 4.37 |
| NYHA Class 3 Year | Hemodynamic | Peak Gradient | 17.69 mmHg | Standard Deviation 8.77 |
| NYHA Class 4 Year | Hemodynamic | Mean Gradient | 8.53 mmHg | Standard Deviation 4.79 |
| NYHA Class 4 Year | Hemodynamic | Peak Gradient | 17.04 mmHg | Standard Deviation 8.75 |
| NYHA Class 5 Year | Hemodynamic | Mean Gradient | 5.55 mmHg | Standard Deviation 1.2 |
| NYHA Class 5 Year | Hemodynamic | Peak Gradient | 10.30 mmHg | Standard Deviation 3.54 |
Primary
Hemodynamics - Effective Orifice Area
Effective orifice area (EOA) data. The effective orifice area is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve.
Time frame: Five Years
Population: At discharge Effective Orifice Area data was collected for 61 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Hemodynamics - Effective Orifice Area | 1.71 EOA (cm2) | Standard Deviation 0.45 |
| NYHA Class 3-6 Months | Hemodynamics - Effective Orifice Area | 1.68 EOA (cm2) | Standard Deviation 0.51 |
| NYHA Class 11-14 Months | Hemodynamics - Effective Orifice Area | 1.70 EOA (cm2) | Standard Deviation 0.46 |
| NYHA Class 2 Year | Hemodynamics - Effective Orifice Area | 1.66 EOA (cm2) | Standard Deviation 0.47 |
| NYHA Class 3 Year | Hemodynamics - Effective Orifice Area | 1.67 EOA (cm2) | Standard Deviation 0.43 |
| NYHA Class 4 Year | Hemodynamics - Effective Orifice Area | 1.62 EOA (cm2) | Standard Deviation 0.41 |
| NYHA Class 5 Year | Hemodynamics - Effective Orifice Area | 1.75 EOA (cm2) | Standard Deviation 0 |
Primary
Hemodynamics - Effective Orifice Area Index
The effective orifice area index is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve.
Time frame: Five Years
Population: At discharge Effective Orifice Area index data was collected for 61 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Hemodynamics - Effective Orifice Area Index | 0.94 EOAi (cm2/m2) | Standard Deviation 0.25 |
| NYHA Class 3-6 Months | Hemodynamics - Effective Orifice Area Index | 0.91 EOAi (cm2/m2) | Standard Deviation 0.27 |
| NYHA Class 11-14 Months | Hemodynamics - Effective Orifice Area Index | 0.93 EOAi (cm2/m2) | Standard Deviation 0.25 |
| NYHA Class 2 Year | Hemodynamics - Effective Orifice Area Index | 0.89 EOAi (cm2/m2) | Standard Deviation 0.25 |
| NYHA Class 3 Year | Hemodynamics - Effective Orifice Area Index | 0.92 EOAi (cm2/m2) | Standard Deviation 0.25 |
| NYHA Class 4 Year | Hemodynamics - Effective Orifice Area Index | 0.89 EOAi (cm2/m2) | Standard Deviation 0.24 |
| NYHA Class 5 Year | Hemodynamics - Effective Orifice Area Index | 1.03 EOAi (cm2/m2) | Standard Deviation 0.06 |
Primary
Hemolysis
Blood data analysis was performed in order to identify whether particular complications and serious adverse events such as hemolysis occurred. Hemolysis in subjects with tissue valves - as evidenced by increased serum lactate dehydrogenase concentrations, decreased serum haptoglobin concentration, erythrocytopenia and reticulocytosis - is usually associated with paravalvular leakage or infection.
Time frame: Five Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Hemolysis | 2 participants |
Primary
Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major)
Any episode of internal or external bleeding in subjects receiving anticoagulant and/or antiaggregant therapy. Hemorrhage/Bleeding (No Anticoagulant/Antiaggregant): Any episode of internal or external bleeding in subjects not receiving anticoagulant and/or antiaggregant therapy. The results are reported as linearized rate (percentage of participants per patient-year).
Time frame: Five Years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major) | All Hemorrhage Bleeding | 1.5 percentage of participants/patient-year |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major) | Major Hemorrhage | 1.5 percentage of participants/patient-year |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major) | Major Hemorrhage Bleeding Anticoagulant | 0.9 percentage of participants/patient-year |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major) | Major Hemorrhage Bleeding No Anticoagulant | 0.6 percentage of participants/patient-year |
Primary
Non-Structural Dysfunction
Any abnormality resulting in stenosis or regurgitation at the operated valve that is not intrinsic to the valve itself. Non-structural dysfunction refers to non-structural problems that result in dysfunction of an operated valve exclusive of thrombosis and infection diagnosed by reoperation, autopsy, or clinical investigation. The results are reported as linearized rate (percentage of participants per patient-year).
Time frame: Five Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Non-Structural Dysfunction | 2.7 percentage of participants/patient-year |
Primary
Paravalvular Leaks (All and Major)
Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis (between the sewing ring and native annulus). Major Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis, i.e. between the sewing ring and native annulus that requires surgical intervention. The results are reported as linearized rate (percentage of participants per patient-year).
Time frame: Five Years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Paravalvular Leaks (All and Major) | All paravalvular leak | 2.4 percentage of participants/patient-year |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Paravalvular Leaks (All and Major) | Major paravalvular leak | 1.5 percentage of participants/patient-year |
Primary
Re-operation, Explant, Repair
Reoperation was defined in the protocol as any operation to repair, alter, or replace the study valve. Included is reoperation for repair of paravalvular leak and explant. The results are reported as linearized rate (percentage of participants per patient-year).
Time frame: Five Years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Re-operation, Explant, Repair | Reoperation (All) | 2.1 percentage of participants/patient-year |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Re-operation, Explant, Repair | Explant | 2.1 percentage of participants/patient-year |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Re-operation, Explant, Repair | Repair | 0 percentage of participants/patient-year |
Primary
Structural Valve Deterioration
Structural deterioration was defined as any change in the study valve function which resulted from an intrinsic abnormality that caused stenosis or regurgitation. There were no cases of structural deterioration reported for the study. The results are reported as linearized rate (percentage of participants per patient-year).
Time frame: Five Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Structural Valve Deterioration | 0 percentage of participants/patient-year |
Primary
Thromboembolism/Thrombosis
Valve related thromboembolism and valvular thrombosis. Thrombosis was defined as any thrombus attached to or near the study valve that interfered with valve function in the absence of infection. The results are reported as linearized rate (percentage of participants per patient-year)
Time frame: Five Years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Thromboembolism/Thrombosis | Late Thromboembolism | 0 percentage of participants/patient-year |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Thromboembolism/Thrombosis | Non-Structural Valve Dysfunction | 2.7 percentage of participants/patient-year |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Thromboembolism/Thrombosis | All PVL | 2.4 percentage of participants/patient-year |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Thromboembolism/Thrombosis | Major Paravalvular Leak | 1.5 percentage of participants/patient-year |
| Enable I Model 6000 Valve: Replacement Aortic Heart Valve | Thromboembolism/Thrombosis | Thrombosis | 0 percentage of participants/patient-year |