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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P140031 S028/ PAS001 |
| Date Original Protocol Accepted |
11/20/2017
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| Date Current Protocol Accepted |
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| Study Name |
SAPIEN 3 Aortic Valve-in-Valve Comp Surv
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| Device Name |
Edwards SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES
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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 |
Infant: 29 days-2 yrs,
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Comprehensive- Linked/Registry Based Surveillance.
The purpose of this Surveillance Plan is to utilize the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry to monitor long term durability, safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve in patients with a failed surgical bioprosthetic aortic valve for 2 years following device approval. Follow-up of these patients will be linked to the Centers for Medicare and Medicaid Services (CMS) database for long-term surveillance through 5 years post implantation.
This is a new enrollment study.
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| Study Population |
Patients with symptomatic heart disease due to a failed surgical bioprosthetic aortic valve (stenosed, insufficient or combined) who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e. predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
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| Sample Size |
Enrollment will consist of all patients with SAPIEN 3 transcatheter heart valve in the STS/ACC TVT Registry for the 2 years following device approval (i.e. from June 5, 2017 to June 4, 2019). All aortic transcatheter SAPIEN 3 Valve in Surgical Valve patients who have the procedure date in the period of June 5, 2017 to June 4, 2019 will be included in the analysis.
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| Key Study Endpoints |
TVT-Captured Safety Endpoints at intra-procedure:
Device Implanted Successfully
TVT-Captured Safety Endpoints at discharge, 30 days and 12 months:
All-cause mortality
All stroke
Life threatening/major bleeding complications*
New requirement of dialysis
Peri-procedural myocardial Infarction
Repeated procedure for valve-related dysfunction (surgical or interventional therapy)
TIA
Vascular complications
*endpoints not available at discharge
TVT-Captured Effectiveness Endpoints (30 days and 12 months):
KCCQ
CMS-Captured Safety Endpoints (year 2 to 5):
All-cause mortality
All Stroke
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
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| Follow-up Visits and Length of Follow-up |
5 years post-implantation
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| Interim or Final Data Summary |
| Interim Results |
TVT-R at 12 Months: All-cause mortality: 12.1% All stroke: 2.8% Life-threatening bleeding: 3.4% Myocardial infarction: 1.5% New Requirement for dialysis: 1.6% Transient ischemic attack (TIA): 0.4% Vascular Complications: 4.1% Aortic valve reintervention: 1.5% KCCQ (Mean Change from Baseline): 39.3 Transvalvular mean gradient: 19.2 mmHg Greater than or equal to Moderate Total Aortic Regurgitation: 1%
Greater than or equal to Moderate Total Aortic Paravalvular Regurgitation: 0.4% CMS Linked at 48 Months: All-cause mortality: 42.5% All-stroke: 9.7%
Aortic Valve Reintervention: 4.0%
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| Actual Number of Patients Enrolled |
TVT Registry: 1,874 (attempted); 1,854 (implanted)
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| Actual Number of Sites Enrolled |
TVT Registry: 408 sites
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| Patient Follow-up Rate |
TVT-R (patient status known at 1 year): 77%
CMS Linked: 81.7% (1282) of eligible patients matched with the CMS database. CMS data was available for 100% of the matched patients at 1, 2, and 3 years and 87.4% of patients at 4 years.
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