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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3f Enable Aortic Bioprosthesis Model 6000 | Experimental | Single arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATS 3f Enable Aortic Bioprosthesis Model 6000 | Device | Replacement Aortic Heart Valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Five Years |
| 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). | Five Years |
| 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). | Five Years |
| 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). | Five Years |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Vang | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | Austria | ||||
| Johann Wolfgang Goethe University |
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| Label | URL |
|---|---|
| Medtronic, Inc. Corporate Website | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ATS 3f Enable Aortic Bioprosthesis Model 6000 | ATS 3f Enable Aortic Bioprosthesis Model 6000 : Replacement Aortic Heart Valve |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
173 subjects were enrolled in the study. Of the 173 subjects enrolled, a cohort of 148 subjects were implanted with, and left the operating room with, the Model 6000 valve. As per protocol, only subjects who left the operating room with the device implanted were followed and included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Aortic Valve Replacement | 3f Enable Aortic Bioprosthesis Model 6000 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Number | 95% Confidence Interval | percentage of participants/patient-year | Five Years |
|
|
5 Years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enable I Model 6000 Valve | Adverse events relating to the study safety endpoints. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Valve-Related Adverse Event | Cardiac disorders | Valve-Related | Non-systematic Assessment | Seventeen out of 148 subjects (11.5%) experienced a Paravalvular Leak (PVL). Of these seventeen PVLs, nine events were reported as minor PVLs and eight events were reported as major PVLs. Three out of the 148 subjects (2.0%) developed endocarditis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unknown Valve Relatedness Adverse Event | Cardiac disorders | Unknown ValveRelated | Non-systematic Assessment | Unknown Valve Relatedness Adverse Event |
Of the 173 subjects enrolled, a cohort of 148 subjects were implanted, followed and included in the analysis. 25 of the 173 subjects enrolled were intraoperative exclusions due to surgeon's discretion during the operative thoracotomy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Palmer, Principal Clinical Research Specialist | Medtronic, Inc. | 763-514-9732 | 49732 | ryan.j.palmer@medtronic.com |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Five Years |
| 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). | Five Years |
| 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). | Five Years |
| 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). | Five Years |
| 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. | Five Years |
| Hemodynamic | Mean and peak pressure gradients from discharge through 5 years follow up. The gradient represents the difference in blood pressure across the valve. | Five Years |
| 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. | Five Years |
| 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. | Five Years |
| Frankfurt |
| Germany |
| University Medical Center Freiburg | Freiburg im Breisgau | Germany |
| University Medical Center Kiel | Kiel | Germany |
| UKSH, Campus Lubeck | Lübeck | Germany |
| Medical University of Gdansk | Gdansk | Poland |
| Jagiellonian University | Krakow | Poland |
| Cardiac Surgery University Hospital Basel | Basel | Switzerland |
| Inselspital Bern | Bern | Switzerland |
| John Radcliffe Hospital | Oxford | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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). | Posted | Number | 95% Confidence Interval | percentage of participants/patient-year | Five Years |
|
|
|
| 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). | Posted | Number | 95% Confidence Interval | percentage of participants/patient-year | Five Years |
|
|
|
| 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). | Posted | Number | 95% Confidence Interval | percentage of participants/patient-year | Five Years |
|
|
|
| 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. | Posted | Number | participants | Five Years |
|
|
|
| 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). | Posted | Number | percentage of participants/patient-year | Five Years |
|
|
|
| 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). | Posted | Number | 95% Confidence Interval | percentage of participants/patient-year | Five Years |
|
|
|
| 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). | Posted | Number | 95% Confidence Interval | percentage of participants/patient-year | Five Years |
|
|
|
| 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. | Posted | Number | participants | Five Years |
|
|
|
| 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. | At discharge, gradient data was collected of 103 subjects. | Posted | Mean | Standard Deviation | mmHg | Five Years |
|
|
|
| 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. | At discharge Effective Orifice Area data was collected for 61 subjects. | Posted | Mean | Standard Deviation | EOA (cm2) | Five Years |
|
|
|
| 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. | At discharge Effective Orifice Area index data was collected for 61 subjects. | Posted | Mean | Standard Deviation | EOAi (cm2/m2) | Five Years |
|
|
|
| 39 |
| 148 |
| 3 |
| 148 |
|
| Not Valve-Related Adverse Event | Cardiac disorders | Not-Valve Related | Non-systematic Assessment | Five of the hemorrhage events were early events and three were late events. |
|
| Unknown Valve-Relatedness Adverse Event | Cardiac disorders | Unknown ValveRelated | Non-systematic Assessment | One out of the 148 subjects (0.7%) implanted experienced an early thromboembolism with a 21 mm valve. This subject experienced a peripheral arterial event, reported as unknown valve relatedness which resolved without permanent sequelae. |
|
|
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| Major Hemorrhage Bleeding No Anticoagulant |
|
| Title | Measurements |
|---|---|
|
| Class II |
|
| Class III |
|
| Class IV |
|
| Unknown |
|
| Peak Gradient |
|