Trial Outcomes & Findings for ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000 (NCT NCT01116024)
NCT ID: NCT01116024
Last Updated: 2018-06-26
Results Overview
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)
COMPLETED
NA
173 participants
Five Years
2018-06-26
Participant Flow
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.
Participant milestones
| Measure |
ATS 3f Enable Aortic Bioprosthesis Model 6000
ATS 3f Enable Aortic Bioprosthesis Model 6000 : Replacement Aortic Heart Valve
|
|---|---|
|
Overall Study
STARTED
|
148
|
|
Overall Study
COMPLETED
|
96
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
Baseline characteristics by cohort
| Measure |
Aortic Valve Replacement
n=148 Participants
3f Enable Aortic Bioprosthesis Model 6000
|
|---|---|
|
Age, Continuous
|
76.0 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
31 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Five YearsValve 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)
Outcome measures
| Measure |
Enable I Model 6000 Valve: Replacement Aortic Heart Valve
n=148 Participants
Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
|
NYHA Class 3-6 Months
NYHA classification after 3-6 months.
|
NYHA Class 11-14 Months
NYHA classification after 11-14 months.
|
NYHA Class 2 Year
NYHA classification after 2 years.
|
NYHA Class 3 Year
NYHA classification after 3 years.
|
NYHA Class 4 Year
NYHA classification after 4 years.
|
NYHA Class 5 Year
NYHA classification after 5 years.
|
|---|---|---|---|---|---|---|---|
|
Thromboembolism/Thrombosis
Late Thromboembolism
|
0 percentage of participants/patient-year
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Thromboembolism/Thrombosis
Non-Structural Valve Dysfunction
|
2.7 percentage of participants/patient-year
Interval 1.4 to 5.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Thromboembolism/Thrombosis
All PVL
|
2.4 percentage of participants/patient-year
Interval 1.2 to 4.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Thromboembolism/Thrombosis
Major Paravalvular Leak
|
1.5 percentage of participants/patient-year
Interval 0.6 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Thromboembolism/Thrombosis
Thrombosis
|
0 percentage of participants/patient-year
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Five YearsAny 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).
Outcome measures
| Measure |
Enable I Model 6000 Valve: Replacement Aortic Heart Valve
n=148 Participants
Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
|
NYHA Class 3-6 Months
NYHA classification after 3-6 months.
|
NYHA Class 11-14 Months
NYHA classification after 11-14 months.
|
NYHA Class 2 Year
NYHA classification after 2 years.
|
NYHA Class 3 Year
NYHA classification after 3 years.
|
NYHA Class 4 Year
NYHA classification after 4 years.
|
NYHA Class 5 Year
NYHA classification after 5 years.
|
|---|---|---|---|---|---|---|---|
|
Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major)
All Hemorrhage Bleeding
|
1.5 percentage of participants/patient-year
Interval 0.6 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major)
Major Hemorrhage
|
1.5 percentage of participants/patient-year
Interval 0.6 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major)
Major Hemorrhage Bleeding Anticoagulant
|
0.9 percentage of participants/patient-year
Interval 0.3 to 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major)
Major Hemorrhage Bleeding No Anticoagulant
|
0.6 percentage of participants/patient-year
Interval 0.1 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Five YearsParavalvular 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).
Outcome measures
| Measure |
Enable I Model 6000 Valve: Replacement Aortic Heart Valve
n=148 Participants
Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
|
NYHA Class 3-6 Months
NYHA classification after 3-6 months.
|
NYHA Class 11-14 Months
NYHA classification after 11-14 months.
|
NYHA Class 2 Year
NYHA classification after 2 years.
|
NYHA Class 3 Year
NYHA classification after 3 years.
|
NYHA Class 4 Year
NYHA classification after 4 years.
|
NYHA Class 5 Year
NYHA classification after 5 years.
|
|---|---|---|---|---|---|---|---|
|
Paravalvular Leaks (All and Major)
All paravalvular leak
|
2.4 percentage of participants/patient-year
Interval 1.2 to 4.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Paravalvular Leaks (All and Major)
Major paravalvular leak
|
1.5 percentage of participants/patient-year
Interval 0.6 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Five YearsEndocarditis 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).
Outcome measures
| Measure |
Enable I Model 6000 Valve: Replacement Aortic Heart Valve
n=148 Participants
Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
|
NYHA Class 3-6 Months
NYHA classification after 3-6 months.
|
NYHA Class 11-14 Months
NYHA classification after 11-14 months.
|
NYHA Class 2 Year
NYHA classification after 2 years.
|
NYHA Class 3 Year
NYHA classification after 3 years.
|
NYHA Class 4 Year
NYHA classification after 4 years.
|
NYHA Class 5 Year
NYHA classification after 5 years.
|
|---|---|---|---|---|---|---|---|
|
Endocarditis
|
0.9 percentage of participants/patient-year
Interval 0.3 to 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Five YearsBlood 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.
Outcome measures
| Measure |
Enable I Model 6000 Valve: Replacement Aortic Heart Valve
n=148 Participants
Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
|
NYHA Class 3-6 Months
NYHA classification after 3-6 months.
|
NYHA Class 11-14 Months
NYHA classification after 11-14 months.
|
NYHA Class 2 Year
NYHA classification after 2 years.
|
NYHA Class 3 Year
NYHA classification after 3 years.
|
NYHA Class 4 Year
NYHA classification after 4 years.
|
NYHA Class 5 Year
NYHA classification after 5 years.
|
|---|---|---|---|---|---|---|---|
|
Hemolysis
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Five YearsStructural 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).
Outcome measures
| Measure |
Enable I Model 6000 Valve: Replacement Aortic Heart Valve
n=148 Participants
Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
|
NYHA Class 3-6 Months
NYHA classification after 3-6 months.
|
NYHA Class 11-14 Months
NYHA classification after 11-14 months.
|
NYHA Class 2 Year
NYHA classification after 2 years.
|
NYHA Class 3 Year
NYHA classification after 3 years.
|
NYHA Class 4 Year
NYHA classification after 4 years.
|
NYHA Class 5 Year
NYHA classification after 5 years.
|
|---|---|---|---|---|---|---|---|
|
Structural Valve Deterioration
|
0 percentage of participants/patient-year
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Five YearsAny 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).
Outcome measures
| Measure |
Enable I Model 6000 Valve: Replacement Aortic Heart Valve
n=148 Participants
Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
|
NYHA Class 3-6 Months
NYHA classification after 3-6 months.
|
NYHA Class 11-14 Months
NYHA classification after 11-14 months.
|
NYHA Class 2 Year
NYHA classification after 2 years.
|
NYHA Class 3 Year
NYHA classification after 3 years.
|
NYHA Class 4 Year
NYHA classification after 4 years.
|
NYHA Class 5 Year
NYHA classification after 5 years.
|
|---|---|---|---|---|---|---|---|
|
Non-Structural Dysfunction
|
2.7 percentage of participants/patient-year
Interval 1.4 to 5.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Five YearsReoperation 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).
Outcome measures
| Measure |
Enable I Model 6000 Valve: Replacement Aortic Heart Valve
n=148 Participants
Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
|
NYHA Class 3-6 Months
NYHA classification after 3-6 months.
|
NYHA Class 11-14 Months
NYHA classification after 11-14 months.
|
NYHA Class 2 Year
NYHA classification after 2 years.
|
NYHA Class 3 Year
NYHA classification after 3 years.
|
NYHA Class 4 Year
NYHA classification after 4 years.
|
NYHA Class 5 Year
NYHA classification after 5 years.
|
|---|---|---|---|---|---|---|---|
|
Re-operation, Explant, Repair
Reoperation (All)
|
2.1 percentage of participants/patient-year
Interval 1.0 to 4.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Re-operation, Explant, Repair
Explant
|
2.1 percentage of participants/patient-year
Interval 1.0 to 4.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Re-operation, Explant, Repair
Repair
|
0 percentage of participants/patient-year
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Five YearsNew 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.
Outcome measures
| Measure |
Enable I Model 6000 Valve: Replacement Aortic Heart Valve
n=148 Participants
Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
|
NYHA Class 3-6 Months
n=119 Participants
NYHA classification after 3-6 months.
|
NYHA Class 11-14 Months
n=109 Participants
NYHA classification after 11-14 months.
|
NYHA Class 2 Year
n=93 Participants
NYHA classification after 2 years.
|
NYHA Class 3 Year
n=71 Participants
NYHA classification after 3 years.
|
NYHA Class 4 Year
n=32 Participants
NYHA classification after 4 years.
|
NYHA Class 5 Year
n=3 Participants
NYHA classification after 5 years.
|
|---|---|---|---|---|---|---|---|
|
Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance
Class I
|
9 participants
|
47 participants
|
51 participants
|
41 participants
|
37 participants
|
10 participants
|
1 participants
|
|
Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance
Class II
|
38 participants
|
61 participants
|
53 participants
|
48 participants
|
29 participants
|
19 participants
|
2 participants
|
|
Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance
Class III
|
92 participants
|
4 participants
|
4 participants
|
4 participants
|
5 participants
|
3 participants
|
0 participants
|
|
Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance
Class IV
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance
Unknown
|
6 participants
|
7 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Five YearsPopulation: At discharge, gradient data was collected of 103 subjects.
Mean and peak pressure gradients from discharge through 5 years follow up. The gradient represents the difference in blood pressure across the valve.
Outcome measures
| Measure |
Enable I Model 6000 Valve: Replacement Aortic Heart Valve
n=103 Participants
Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
|
NYHA Class 3-6 Months
n=98 Participants
NYHA classification after 3-6 months.
|
NYHA Class 11-14 Months
n=89 Participants
NYHA classification after 11-14 months.
|
NYHA Class 2 Year
n=74 Participants
NYHA classification after 2 years.
|
NYHA Class 3 Year
n=62 Participants
NYHA classification after 3 years.
|
NYHA Class 4 Year
n=42 Participants
NYHA classification after 4 years.
|
NYHA Class 5 Year
n=2 Participants
NYHA classification after 5 years.
|
|---|---|---|---|---|---|---|---|
|
Hemodynamic
Mean Gradient
|
10.28 mmHg
Standard Deviation 4.37
|
9.02 mmHg
Standard Deviation 3.70
|
8.59 mmHg
Standard Deviation 3.19
|
8.52 mmHg
Standard Deviation 3.39
|
8.77 mmHg
Standard Deviation 4.37
|
8.53 mmHg
Standard Deviation 4.79
|
5.55 mmHg
Standard Deviation 1.20
|
|
Hemodynamic
Peak Gradient
|
20.38 mmHg
Standard Deviation 8.40
|
18.15 mmHg
Standard Deviation 7.17
|
16.58 mmHg
Standard Deviation 6.16
|
16.65 mmHg
Standard Deviation 6.89
|
17.69 mmHg
Standard Deviation 8.77
|
17.04 mmHg
Standard Deviation 8.75
|
10.30 mmHg
Standard Deviation 3.54
|
PRIMARY outcome
Timeframe: Five YearsPopulation: At discharge Effective Orifice Area data was collected for 61 subjects.
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.
Outcome measures
| Measure |
Enable I Model 6000 Valve: Replacement Aortic Heart Valve
n=61 Participants
Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
|
NYHA Class 3-6 Months
n=73 Participants
NYHA classification after 3-6 months.
|
NYHA Class 11-14 Months
n=66 Participants
NYHA classification after 11-14 months.
|
NYHA Class 2 Year
n=51 Participants
NYHA classification after 2 years.
|
NYHA Class 3 Year
n=44 Participants
NYHA classification after 3 years.
|
NYHA Class 4 Year
n=34 Participants
NYHA classification after 4 years.
|
NYHA Class 5 Year
n=2 Participants
NYHA classification after 5 years.
|
|---|---|---|---|---|---|---|---|
|
Hemodynamics - Effective Orifice Area
|
1.71 EOA (cm2)
Standard Deviation 0.45
|
1.68 EOA (cm2)
Standard Deviation 0.51
|
1.70 EOA (cm2)
Standard Deviation 0.46
|
1.66 EOA (cm2)
Standard Deviation 0.47
|
1.67 EOA (cm2)
Standard Deviation 0.43
|
1.62 EOA (cm2)
Standard Deviation 0.41
|
1.75 EOA (cm2)
Standard Deviation 0.0
|
PRIMARY outcome
Timeframe: Five YearsPopulation: At discharge Effective Orifice Area index data was collected for 61 subjects.
The effective orifice area index is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve.
Outcome measures
| Measure |
Enable I Model 6000 Valve: Replacement Aortic Heart Valve
n=61 Participants
Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
|
NYHA Class 3-6 Months
n=73 Participants
NYHA classification after 3-6 months.
|
NYHA Class 11-14 Months
n=66 Participants
NYHA classification after 11-14 months.
|
NYHA Class 2 Year
n=51 Participants
NYHA classification after 2 years.
|
NYHA Class 3 Year
n=44 Participants
NYHA classification after 3 years.
|
NYHA Class 4 Year
n=34 Participants
NYHA classification after 4 years.
|
NYHA Class 5 Year
n=2 Participants
NYHA classification after 5 years.
|
|---|---|---|---|---|---|---|---|
|
Hemodynamics - Effective Orifice Area Index
|
0.94 EOAi (cm2/m2)
Standard Deviation 0.25
|
0.91 EOAi (cm2/m2)
Standard Deviation 0.27
|
0.93 EOAi (cm2/m2)
Standard Deviation 0.25
|
0.89 EOAi (cm2/m2)
Standard Deviation 0.25
|
0.92 EOAi (cm2/m2)
Standard Deviation 0.25
|
0.89 EOAi (cm2/m2)
Standard Deviation 0.24
|
1.03 EOAi (cm2/m2)
Standard Deviation 0.06
|
Adverse Events
Enable I Model 6000 Valve
Serious adverse events
| Measure |
Enable I Model 6000 Valve
n=148 participants at risk
Adverse events relating to the study safety endpoints.
|
|---|---|
|
Cardiac disorders
Valve-Related Adverse Event
|
12.8%
19/148 • Number of events 19 • 5 Years
|
|
Cardiac disorders
Not Valve-Related Adverse Event
|
11.5%
17/148 • Number of events 17 • 5 Years
|
|
Cardiac disorders
Unknown Valve-Relatedness Adverse Event
|
2.0%
3/148 • Number of events 3 • 5 Years
|
Other adverse events
| Measure |
Enable I Model 6000 Valve
n=148 participants at risk
Adverse events relating to the study safety endpoints.
|
|---|---|
|
Cardiac disorders
Unknown Valve Relatedness Adverse Event
|
2.0%
3/148 • Number of events 3 • 5 Years
|
Additional Information
Ryan Palmer, Principal Clinical Research Specialist
Medtronic, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place