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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P140031 S085/ PAS002 |
| Date Original Protocol Accepted |
08/16/2019
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| Date Current Protocol Accepted |
|
| Study Name |
SAPIEN 3 Registry-Based Cont Access & Low Risk RWU
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| Device Name |
SAPIEN 3 Ultra transcatheter heart valve
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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 |
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 CAP cohort annually through 10 years post implantation and to assess the real-world use of the commercial SAPIEN 3 Transcatheter Heart Valve System and SAPIEN 3 Ultra Transcatheter Heart Valve 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 |
Tricuspid Low Risk TVTR CAP at 1 Year:
All-cause death: 0.9%
All stroke: 2.3%
Transient ischemic attack: 0.8%
Rehospitalization (Device or procedural related or heart failure): 4.8%
Aortic valve re-intervention (site reported): 0.9%
Life-threatening/major bleeding (site reported): 1.6%
Major vascular complications (site reported): 0.9%
New requirement for dialysis (site reported): 0%
NYHA (% in class I/II): 99.4%
KCCQ (Mean Change from Baseline): 24.6
Transvalvular mean gradient: 13.3
Greater than or equal to Moderate PVL: 3.6%
Tricuspid Low Risk TVTR CAP (CMS-linked) at 3 years:
All-cause death: 6.0%
Stroke: 5.2%
Aortic valve reintervention: 1.6%
TVTR Low Risk Tricuspid Cohort at 1 Year:
All-cause death: 4.4%
All stroke: 2.1%
Life-threatening bleeding: 1.4%
Myocardial infarction: 0.7%
New requirement for dialysis: 0.2%
Transient ischemic attack (TIA): 0.7%
Major Vascular Complications: 0.9%
Aortic valve reintervention: 0.4%
New permanent pacemaker implantation (site reported): 8.2%
Prosthetic valve endocarditis (site reported): 0.4%
Prosthetic valve thrombosis (site reported): 0.2%
NYHA (% in class I/II): 95.7%
KCCQ (Mean Change from Baseline): 27.5
Transvalvular mean gradient: 13.1
Greater than or equal to Moderate PVL: 1.5%
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| Actual Number of Patients Enrolled |
CAP Cohort:
Tricuspid: A total of 893 subjects were enrolled, of which 889 were included in the valve implant population.
TVTR Low Risk Tricuspid Cohort: A total of 24,262 subjects were treated. Of these, 24,064 subjects were included in the VI population.
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| Actual Number of Sites Enrolled |
Tricuspid Low Risk TVTR CAP: 43 sites
TVTR Low Risk Tricuspid Cohort: 703 sites
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| Patient Follow-up Rate |
Tricuspid Low Risk TVTR CAP:
Patient status known at 1 year: 90.3%
TVTR Low Risk Tricuspid Cohort:
Patient status known at 1 year: 83.7%
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