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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P140031 S074/ PAS001 |
| Date Original Protocol Accepted |
12/27/2018
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| Date Current Protocol Accepted |
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| Study Name |
SAPIEN 3 Ultra Novel Surveillance
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| Device Name |
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System
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| Clinical Trial Number(s) |
NCT03471065
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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 objective of the surveillance is to assess the real-world use of the commercial SAPIEN 3 Ultra Transcatheter Heart Valve System for native aortic valve replacement in patients at intermediate and above surgical risk and for aortic and mitral valve-in-valve in patients at high and above surgical risk.
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| Study Population |
The surveillance 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 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 5 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 2-5 year post-implantation.
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| Follow-up Visits and Length of Follow-up |
5 years
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| Interim or Final Data Summary |
| Interim Results |
Native:
1 year (TVT-R): all-cause death: 13.1%; all stroke: 3.3%; valve reintervention: 0.2%; KCCQ (mean change in summary score from baseline): 30.3 ± 0.33; NYHA (% in Class I/II): 91.6%; PVL = moderate: 1.5%; mean aortic gradient: 12.7 mmHg (compared to baseline mean gradient of 41.5 mmHg)
2-years (CMS-linked): all-cause death: 24.8%; all-stroke: 6.7%; valve re-intervention: 0.4%
Aortic THV-in-SV:
1 year (TVT-R): all-cause death: 14.6%; all stroke: 3.1%; valve reintervention: 2.9%; KCCQ (mean change in summary score from baseline): 37.9 ± 2.15; NYHA (% in Class I/II): 90.7%; PVL = moderate: 1.0%; mean aortic gradient: 18.8 mmHg (compared to baseline mean gradient of 36.6 mmHg)
2-years (CMS-linked): all-cause death: 23.5%; all-stroke: 6.6%; valve re-intervention: counts too small to report per data use agreement
Mitral THV-in-SV:
1 year (TVT-R): all-cause death: 18.9%; all stroke: 5.3%; valve reintervention: 0.6%; KCCQ (mean change in summary score from baseline): 40.5 ± 3.34; NYHA (% in Class I/II): 86.8%; PVL = moderate: 2.3%; mean mitral gradient: 8.0 mmHg (compared to baseline mean gradient of 14.2 mmHg)
2-years (CMS-linked): all-cause death: 28.6%; all-stroke and valve re-intervention: counts too small to report per data use agreement
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| Actual Number of Patients Enrolled |
Native: 14,226 patients (attempted); 14,096 patients implanted
Aortic THV-in-Surgical Valve: 492 patients (attempted); 486 patients were implanted
Mitral THV-in-Surgical Valve: 172 patients (attempted); 164 implanted
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| Actual Number of Sites Enrolled |
N/A
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| Patient Follow-up Rate |
Native:
30 Days: Patient status known: 96.4%;
1 Year: Patient status known: 80.4%;
2 Years: 85.6% of eligible patients (11,608/13,562) matched within the CMS database. CMS data was available for 100% of matched patients at 2 years.
Aortic THV-in-SV:
30 Day: Patient status known: 96.3%;
1 Year: Patient status known: 79.7%;
2 Years: 84.8% of eligible patients (362/427) matched within the CMS database. CMS data was available for 100% of matched patients at 2 years.
Mitral THV-in-SV:
30 Day: Patient status known: 94.2%;
1 Year: Patient status known: 70.9%;
2 Years: 77.2% of eligible patients (112/145) matched within the CMS database. CMS data was available for 100% of matched patients at 2 years.
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