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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130021 S016/ PAS001 |
| Study Name |
Continued f/u of premarket cohort
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| Device Name |
MEDTRONIC COREVALVE AND COREVALVE EVOLUT R SYSTEMS
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of premarket cohorts. The objective of this study is to characterize the cumulative clinical outcomes of all subjects through 5 years post procedure.
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| Study Population |
The study will consist of all living subjects who were enrolled in the ¿Low Flow Low Gradient¿ (LFLG) and ¿End-Stage Renal Disease¿ (ESRD) cohorts under the IDE.
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| Sample Size |
All living subjects.
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| Key Study Endpoints |
The safety and effectiveness endpoints include all-cause mortality or major stroke at 6 months, 12 months and annually through 5 years and the following at 30 days, 6 months, and annually through 5 years: major adverse cardiovascular and cerebrovascular event (MACCE) event rate; occurrence of individual MACCE components; major adverse events (MAE); conduction disturbance requiring permanent pacemaker implantation; change in New York Heart Association (NYHA) classification; quality of life (QoL) change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-12, and EuroQoL; echocardiographic assessment of valve performance; aortic valve disease hospitalization; cardiovascular deaths and valve-related deaths; strokes (of any severity) and transient ischemic attacks (TIAs); and evidence of prosthetic valve dysfunction.
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| Follow-up Visits and Length of Follow-up |
5 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
133 subjects (ESRD)
215 subjects (LFLG)
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| Actual Number of Sites Enrolled |
36 (ESRD)
28 (LFLG)
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| Patient Follow-up Rate |
The follow-up rate through 5 years was approximately 95% for the ESRD cohort and 97% for the LFLG cohort
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| Final Safety Findings |
The Kaplan-Meier rates of CEC-adjudicated safety outcomes at 5 years are summarized as follows:
ESRD Cohort
All-cause mortality or major stroke: 89.9%
All-cause mortality: 89.9%
Cardiovascular mortality: 68.5%
All stroke: 13.3% (9.9% major stroke)
Bleed: 56.3%
Valve-related death: 9.8%
Aortic valve hospitalization: 36.3%
Reintervention: 1.8%
Major adverse cardiovascular and cerebrovascular event (MACCE): 90.9%
New PPM: 50.8%
LFLG Cohort
All-cause mortality or major stroke: 74.4%
All-cause mortality: 74%
Cardiovascular mortality: 56.9%
All stroke: 18.5% (13.8% major stroke)
Bleed: 38.9%
Valve-related death: 7.6%
Aortic valve hospitalization: 50.4%
Reintervention: 5%
Major adverse cardiovascular and cerebrovascular event (MACCE): 78.1%
New PPM: 45.9%
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| Final Effect Findings |
Key effectiveness outcomes are summarized as follows, in subjects who were evaluated for each outcome measure at the 5-year visit:
ESRD Cohort
NYHA Classification: There was improvement in NYHA classification from baseline to 5-years. The mean change compared to baseline at 5 years was -1.2 +/- 0.8 (n=9).
KCCQ: Improvement was observed in both overall and clinical summary scores through five years. The change in KCCQ overall summary score at 5 years compared to baseline was 15.2 +/- 30.0 (n=9).
Valve Performance Outcomes:
Mean gradient decreased from 45.03 +/- 13.61 at baseline to 9.02 +/- 3.92 at 30 days. At 5-years, the overall mean gradient was 7.71 + 3.55 mmHg (n=8).
Mean effective orifice area (EOA) increased from 0.72 +/- 0.20 cm2 at baseline to 1.77 +/- 0.47 cm2 at 30 days. At 5 years, the EOA was 1.70 + 0.84 cm2 (n=8).
At 5 years, 100% of subjects with available echocardiographic data (n=8) had mild or less total aortic regurgitation (AR).
LFLG Cohort
NYHA Classification: There was improvement in NYHA classification from baseline to 5-years. The mean change compared to baseline at 5 years was -1.2 +/- 0.7 (n=33).
KCCQ: Improvement was observed in both overall and clinical summary scores through five years. The change in KCCQ overall summary score at 5 years compared to baseline was 20.9 +/- 24.9 (n=35).
Valve Performance Outcomes:
Mean gradient decreased from 28.41 +/- 5.06 at baseline to 6.40 +/- 3.23 at 30 days. At 5-years, the overall mean gradient was 6.21 +/- 3.65 mmHg (n=32).
Mean effective orifice area (EOA) increased from 0.77 +/- 0.19 cm2 at baseline to 1.83 +/- 0.55 cm2 at 30 days. At 5 years, the EOA was 1.96 +/- 0.77 cm2 (n=29).
At 5 years, 93.6% of subjects with available echocardiographic data (n=32) had mild or less total aortic regurgitation (AR).
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| Study Strengths & Weaknesses |
This continued follow-up study provides longer-term data (through 5 years) on the safety and effectiveness of the Medtronic CoreValve System in patients with symptomatic severe aortic stenosis with predicted operative mortality or serious, irreversible morbidity risk of > 50% at 30 days who have end stage renal disease or low gradient, low output aortic stenosis. Generally, outcomes suggest that safety and effectiveness is maintained through 5 years post procedure, with meaningful improvements shown for both cohorts from baseline to 5 years. However, Echocardiography Corelab and Quality of Life compliance rates at 5 years are low for both cohorts (44-65%). The incomplete data may impact the ability to interpret and draw conclusions from the results.
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| Recommendations for Labeling Changes |
The labeling is recommended to be updated to reflect the 5 year findings of the study and should be informative to clinicians and patients regarding the longer-term benefit risk profile for the device.
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