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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P130021 S058/ PAS002 |
| Date Original Protocol Accepted |
08/16/2019
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| Date Current Protocol Accepted |
03/20/2020
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| Study Name |
Evolut R and PRO Sys Registry-Based Low Risk RWU
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| Device Name |
Medtronic CoreValve™ Evolut™ R System and Medtronic CoreValve™ Evolut™ Pro System
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| Clinical Trial Number(s) |
NCT02701283
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| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
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| Data Source |
External Registry
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| Comparison Group |
Historical 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 |
Comprehensive/linked/registry-based surveillance. The objectives of the surveillance are to characterize the clinical outcomes of the Continued Access Protocol (CAP) cohort annually through 10 years post implantation and to assess the real-world use of the commercial Medtronic CoreValve Evolut R System and CoreValve Evolut PRO System to ensure that the device is used in appropriate circumstances.
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| Study Population |
The surveillance of the CAP cohort will consist of all living CAP patients who were enrolled at participating institutions, and the surveillance of the real-world use will involve all consecutive patients treated within the first 2 years that are entered into the TVT Registry (enrollment period)
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| Sample Size |
All living CAP subjects and all consecutive patients treated within the first 2 years in the commercial setting that are entered into the TVT Registry.
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| Key Study Endpoints |
The clinical data through one (1) year will be collected through the TVT Registry; and the follow-up data from year 2 through year 10 post procedure will be obtained through linking the TVT data with the Centers for Medicare and Medicaid Services (CMS) claims database. The surveillance will monitor the following: (1) device success (intra-procedure); (2) all-cause mortality, all stroke, life-threatening/major bleeding, new requirement for dialysis, peri-procedural myocardial infarction, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 30 days and 12 months; (3) neurological (non-stroke), vascular complications, and quality of life (KCCQ) outcomes at 30 days and 12 months; and (4) all-cause mortality, all stroke, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 2-10 year post implantation.
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| Follow-up Visits and Length of Follow-up |
10 years
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| Interim or Final Data Summary |
| Interim Results |
TVT Registry at 30 days and 1 year: Real World Surveillance Low Risk Cohort K-M Adverse Event Rates: All-cause mortality: 1.2% at 30 days; 5.1% at 1 year Any Stroke: 2.7% at 30 days; 3.6% at 1 year Life-threatening/major bleeding: 3.9% at 30 days; 4.8% at 1 year Vascular Complication: 3.8% at 30 days; 4.0% at 1 year New requirement for dialysis: 0.2% at 30 days; 0.3% at 1 year Myocardial infarction: 0.3% at 30 days; 1.1% at 1 year Aortic Valve Re-intervention: 0.4% at 30 days; 0.7% at 1 year KCCQ: Change from Baseline to 1-Month at 30 days: 25.7 + 24.3; Change from Baseline to 1-Month at 1-Year: 27.5 + 23.9.
Low Risk CAP Cohort K-M Adverse Event Rates: All-cause mortality: 0.7% at 30 days; 2.3% at 1 year Any Stroke: 2.7% at 30 days; 3.6% at 1 year Life-threatening/major bleeding: 3.4% at 30 days; 3.8% at 1 year Vascular Complication: 2.8% at 30 days; 3.1% at 1 year New requirement for dialysis: 0.0% at 30 days; 0.1% at 1 year Myocardial infarction: 0.1% at 30 days; 0.5% at 1 year Aortic Valve Re-intervention: 0.3% at 30 days; 0.8% at 1 year KCCQ: Change from Baseline to 1-Month at 30 days: 21.3 + 23.0; Change from Baseline to 1-Month at 1-Year: 24.7 + 22.8
TVT-R/CMS Linked Data: Real World Surveillance Low Risk Cohort: All-Cause Mortality: 5.9% at 1 year Any Stroke: 4.8% at 1 year Aortic Valve Re-intervention: 0.8% at 1 year.
Low Risk CAP: All-Cause Mortality: 3.6% at 2 years Any Stroke: 5.9% at 2 years Aortic Valve Re-intervention: 1.0% at 2 years
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| Actual Number of Patients Enrolled |
Real World Surveillance Low Risk Cohort: 7,440
Low Risk CAP Cohort: 745
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| Actual Number of Sites Enrolled |
Registry based
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| Patient Follow-up Rate |
Real World Surveillance Low Risk Cohort: TVT-R: 30 day: 89.3%; 12 months: 83.3% TVT-R/CMS Linked Data: 7,490; 5,338 (71%) were uniquely matched to CMS claims and encounter data.
Low Risk CAP: TVT-R: 30 day: 99.6%; 12 month: 97.5% TVT-R/CMS Linked Data: Total Patients: 745; 616 (82%) were uniquely matched to CMS claims and encounter data.
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