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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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| 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: Procedural success rate: 99.0%, 30 days: all-cause (2.2%) and cardiovascular (0.8%) mortality, all stroke (1.9%), life threatening/major bleeding: 0.8%, new requirement for dialysis: 0.5%, myocardial infarction: 0.3%, aortic valve reintervention: 0.1%, and major vascular complications: 1.5%; 1 year: all-cause and cardiac death were 12.9% and 2.9%, respectfully. The reported all stroke rate was 3.2%. Aortic valve reintervention: 0.2%.
Aortic THV-in-SV: Procedural success rate: 98.8%, 30 days: all-cause (4.6%) and cardiovascular (2.7%) mortality, all stroke (1.5%), life threatening/major bleeding: 1.0%, new requirement for dialysis: 1.9%, myocardial infarction: 1.0%, aortic valve reintervention: 0.6%, and major vascular complications (2.0%); 1 year: all-cause and cardiac death were 14.4% and 6.1%, respectfully. The reported all stroke rate at one-year was 2.8%. Aortic valve reintervention: 2.9%.
Mitral THV-in-SV: Procedural success rate was 95.3%. 30 days:
all-cause (8.5%) and cardiovascular mortality (3.6%), all strokes (2.5%), life threatening/major bleeding: 0.6%, new requirement for dialysis: 3.1%, mitral valve reintervention: 0.6%, and major vascular complications: 1.8%.
1 year: all-cause and cardiac death were 19.0% and 7.0%, respectfully. The reported all stroke rate at one-year was 5.4%. Mitral valve reintervention: 0.6%.
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| Actual Number of Patients Enrolled |
Native: A total of 14,226 patients underwent treatment with the SAPIEN 3 Ultra THV between January 22, 2019 and December 24, 2020. The procedure was attempted in 14,226 patients (AI population), and 14,096 patients were implanted with the SAPIEN 3 Ultra THV (VI population).
Aortic THV-in-Surgical Valve: A total of 495 patients underwent treatment with the SAPIEN 3 Ultra System for aortic THVin-SV procedures. The procedure was attempted in 495 patients (AI population), and 486 patients were implanted with the SAPIEN 3 Ultra THV (VI population).
Mitral THV-in-Surgical Valve: A total of 172 patients underwent treatment with the SAPIEN 3 Ultra System for mitral THVin-SV procedures. The procedure was attempted in 172 patients (AI population), and 164 patients were implanted with the SAPIEN 3 Ultra THV (VI population).
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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%; Patient status unknown: 3.6% (1.4% lost to follow-up). 1 Year: Patient status known: 80.4%; Patient status unknown: 19.6% (5.1% lost to follow-up); Aortic THV-in-SV: 30 Day: Patient status known: 96.3%; Patient status unknown: 3.7% (1.2% lost to follow-up). 1 Year: Patient status known: 79.7%; Patient status unknown: 20.3% (6.3% lost to follow-up); Mitral THV-in-SV: 30 Day: Patient status known: 94.2%; Patient status unknown: 5.8% (2.9% lost to foll
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| Final Safety Findings |
Native: Procedural success rate: 99.0%, 30 days: all-cause (2.2%) and cardiovascular (0.8%) mortality, all stroke (1.9%), life threatening/major bleeding: 0.8%, new requirement for dialysis: 0.5%, myocardial infarction: 0.3%, aortic valve reintervention: 0.1%, and major vascular complications: 1.5%; 1 year: all-cause and cardiac death were 12.9% and 2.9%, respectfully. The reported all stroke rate was 3.2%. Aortic valve reintervention: 0.2%.
Aortic THV-in-SV: Procedural success rate: 98.8%, 30 days: all-cause (4.6%) and cardiovascular (2.7%) mortality, all stroke (1.5%), life threatening/major bleeding: 1.0%, new requirement for dialysis: 1.9%, myocardial infarction: 1.0%, aortic valve reintervention: 0.6%, and major vascular complications (2.0%); 1 year: all-cause and cardiac death were 14.4% and 6.1%, respectfully. The reported all stroke rate at one-year was 2.8%. Aortic valve reintervention: 2.9%.
Mitral THV-in-SV: Procedural success rate was 95.3%. 30 days:
all-cause (8.5%) and cardiovascular mortality (3.6%), all strokes (2.5%), life threatening/major bleeding: 0.6%, new requirement for dialysis: 3.1%, mitral valve reintervention: 0.6%, and major vascular complications: 1.8%.
1 year: all-cause and cardiac death were 19.0% and 7.0%, respectfully. The reported all stroke rate at one-year was 5.4%. Mitral valve reintervention: 0.6%.
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| Final Effect Findings |
Native: Mean gradient decreased from 41.5 mmHg at baseline to 12.2 mmHg at 30 days and 12.7 mmHg at one year. Rates of moderate or greater total PVL were (0.7%) at 30 days and one year (1.5%), with over 86% of patients exhibiting no PVL
through one year. Quality of life, as measured by KCCQ scores, improved by 28.9 points at 30 days and 30.1 points at one year. Most patients showed improvement in NYHA function at
30 days (80.0%) and one year (80.5%).
Aortic THV-in-SV: Mean gradient decreased from 36.6 mmHg at baseline to 20.1 mmHg at 30 days and 18.9 mmHg at one year. Rates of moderate or greater total PVL were (0.6%) at 30 days and one year (1.0%), with 98% of patients exhibiting no PVL through
one year. Quality of life, as measured by KCCQ scores, improved by 35.6 points at 30 days and 37.2 points at one year. Most patients showed improvement in NYHA function at 30 days (84.2%) and one year (87.5%).
Mitral THV-in-SV: Mean gradient decreased from 14.2 mmHg at baseline to 8.0 mmHg at 30 days and 8.0 mmHg at one year. At 30 days, no reports of moderate or greater total PVL
was reported by subjects. At one-year, the rate of moderate or greater total PVL was (2.3%), with over 95% of patients exhibiting no PVL through one year. Quality of life, as measured by KCCQ scores, improved by 36.9 points at 30 days and 40.5 points at one year. Most patients showed improvement in NYHA function at 30 days (79.8%) and one year (82.4%)
Native: Mean gradient decreased from 41.5 mmHg at baseline to 12.2 mmHg at 30 days and 12.7 mmHg at one year. Rates of moderate or greater total PVL were (0.7%) at 30 days and one year (1.5%), with over 86% of patients exhibiting no PVL
through one year. Quality of life, as measured by KCCQ scores, improved by 28.9 points at 30 days and 30.1 points at one year. Most patients showed improvement in NYHA function at
30 days (80.0%) and one year (80.5%).
Aortic THV-in-SV: Mean gradient decreased from 36.6 mmHg at baseline to 20.1 mmHg at 30 days and 18.9 mmHg at one year. Rates of moderate or greater total PVL were (0.6%) at 30 days and one year (1.0%), with 98% of patients exhibiting no PVL through
one year. Quality of life, as measured by KCCQ scores, improved by 35.6 points at 30 days and 37.2 points at one year. Most patients showed improvement in NYHA function at 30 days (84.2%) and one year (87.5%).
Mitral THV-in-SV: Mean gradient decreased from 14.2 mmHg at baseline to 8.0 mmHg at 30 days and 8.0 mmHg at one year. At 30 days, no reports of moderate or greater total PVL
was reported by subjects. At one-year, the rate of moderate or greater total PVL was (2.3%), with over 95% of patients exhibiting no PVL through one year. Quality of life, as measured by KCCQ scores, improved by 36.9 points at 30 days and 40.5 points at one year. Most patients showed improvement in NYHA function at 30 days (79.8%) and one year (82.4%)
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