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|
| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P130021 S174/ PAS001 |
| Date Original Protocol Accepted |
08/27/2025
|
| Date Current Protocol Accepted |
08/27/2025
|
| Study Name |
Registry-Based Real-World Use Surveillance
|
| Device Name |
Evolut PRO+ System, Evolut FX System, Evolut FX+ System
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
External Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Characterize long-term clinical outcomes for the Evolut PRO+, Evolut FX, and Evolut FX+ Systems in patients with a failing aortic transcatheter bioprosthetic valve after PMA approval through the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) registry-based surveillance.
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| Study Population |
All patients entered into the TVT Registry database and treated with the Evolut PRO+, Evolut FX, or Evolut FX+ System for the first 2 years following device approval or a total of 500 consecutively treated such patients, whichever is greater, will be included as part of this registry-based post-approval surveillance.
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| Sample Size |
All consecutive patients treated within the first 2 years following device approval or a total of 500 consecutively treated such patients, whichever is greater, that are entered into the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry (enrollment period).
|
| Key Study Endpoints |
Primary Endpoints
• Device success (intra-procedure) collected as device implanted successfully in TVT-R
• Clinical event outcomes at 30 days and 1 year (collected in TVT-R):
o All-cause mortality
o All stroke
o Life-threatening / major bleeding
o New requirement for dialysis
o Myocardial infarction
o Repeat procedure for valve-related dysfunction (surgical or interventional therapy), collected as aortic valve reintervention
o Neurological (non-stroke) collected as transient ischemic attack
o Vascular complications (major and minor)
• Quality of life (as measured by KCCQ) outcomes at 30 days and 1 year (collected in TVT-R)
• All-cause mortality, all stroke, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 2 – 10 years post implantation (collected through CMS claims and encounter data)
Secondary Endpoints
In-hospital coronary artery obstruction or compression, 30-day and 1-year echo measurements (including mean gradient, effective orifice area, and aortic regurgitation), and 30-day and 1-year NYHA classification scores collected in TVT-R will be summarized.
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| Follow-up Visits and Length of Follow-up |
10 years
|
