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General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P140031 S107/ PAS002 |
Date Original Protocol Accepted |
07/22/2020
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Date Current Protocol Accepted |
 
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Study Name |
CAP Cohort and Low Risk Bicuspid RWU Surveillance
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Device Name |
Sapien 3 and Sapien 3 Ultra Transcatheter Heart Valves
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Clinical Trial Number(s) |
NCT02675114
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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 |
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 |
Comprehensive/linked/registry-based surveillance. The objectives of the surveillance are to characterize the clinical outcomes of the CAP cohort annually through 10 years post implantation and to assess the real-world use of the commercial SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System to ensure that the device is used in appropriate circumstances, respectively.
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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 - All subjects are followed annually through 10 years post procedure
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Interim or Final Data Summary |
Interim Results |
Bicuspid Low Risk TVTR CAP at 1 Year: All-cause death: 0.0% All stroke: 1.1% Transient ischemic attack (TIA): 0.0% Rehospitalization (Device or procedural related or heart failure): 7.1% Aortic valve re-intervention (site reported): 1.0% Life-threatening/major bleeding (site reported): 0.0% Major vascular complications (site reported): 3.1% New requirement for dialysis (site reported): 0.0% NYHA (% in class I/II): 98.9% KCCQ (Mean Change from Baseline): 30.4 Transvalvular mean gradient: 13.0 Greater than or equal to Moderate PVL: 3.0%
Bicuspid Low Risk TVTR CAP (CMS-linked) at 3 Years: All-cause death: 3.7% Stroke: 1.2% Aortic valve reintervention: 3.7%
TVTR Bicuspid Cohort at 1 Year: All-cause death: 3.0% All stroke: 2.1% Life-threatening bleeding: 1.2% Myocardial infarction: 0.3% New requirement for dialysis: 0.2% Transient ischemic attack (TIA): 0.7% Major Vascular Complications: 0.8% Aortic valve reintervention: 0.8% New permanent pacemaker implantation: 8.3% Prosthetic valve endocarditis: 0.3% Prosthetic valve thrombosis: 0.5% NYHA (% in class I/II): 97.1% KCCQ (Mean Change from Baseline): 27.2 Transvalvular mean gradient: 13.6 Greater than or equal to Moderate PVL: 2.9%
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Actual Number of Patients Enrolled |
Bicuspid Low Risk TVTR CAP: 98 subjects
TVTR Bicuspid Cohort: 3,546
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Actual Number of Sites Enrolled |
Bicuspid Low Risk TVTR CAP: 34 sites
TVTR Bicuspid Cohort: 531 sites
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Patient Follow-up Rate |
Bicuspid Low Risk TVTR CAP: 93.9%
TVTR Bicuspid Cohort: 85.3%
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