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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P190023 S002/ PAS002 |
| Date Original Protocol Accepted |
01/13/2023
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| Date Current Protocol Accepted |
|
| Study Name |
Registry-Based Real-World Use Surveillance Study
|
| Device Name |
Navitor Transcatheter Aortic Valve Implantation System; Navitor Transcatheter Aortic Heart Valve; FlexNav Delivery System; Navitor Loading System
|
| Clinical Trial Number(s) |
NCT04011722
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
External Registry
|
| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The primary objective of this PAS is to confirm the long-term safety and effectiveness of the Navitor valve for patients at high or greater surgical risk, undergoing TAVR with the Navitor valve and FlexNav delivery system (DS) in a contemporary real-world setting. The study is an observational real-world surveillance study
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| Study Population |
All patients that have undergone attempted TAVR with Navitor valve (23, 25, 27, or 29-mm sizes) using FlexNav Delivery System at a TVT Registry participating site, from the date of PMA approval (January 13, 2023) through January 13, 2025, who are at “high or greater risk” of mortality with open surgery.
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| Sample Size |
There is no minimum sample size. The PAS will include all consecutive patients who have a Navitor valve with FlexNav Delivery System implant attempt at institutions participating in the STS/ACC TVT Registry within the first 2 years following PAS start date.
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| Key Study Endpoints |
This surveillance will monitor the following: (1) device success (intra-procedure); (2) all-cause mortality, all stroke, life-threatening/major bleeding, new requirement for dialysis, new pacemaker implant, 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) annually at 2-5 year post implantation.
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| Follow-up Visits and Length of Follow-up |
5 years post-implant
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| Interim or Final Data Summary |
| Interim Results |
Safety Results
• 30-days endpoints:
o All-cause mortality = 3.3%
o All stroke = 2.6%
o Life threatening or major bleeding = 0.7%
o New requirement for dialysis = 0.4%
o New permanent pacemaker implantation = 18.4%
o Peri-procedural myocardial infarction = 0.4%
o Reintervention – Aortic valve related = 0.3%
o Neurological (TIA / non-stroke) events = 0.3%
o Major vascular complications = 2.1%
o Minor vascular complications = 4.2%
o Kansas City Cardiomyopathy Questionnaire (KCCQ) - 76.3 (51.4 pre-procedure)
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| Actual Number of Patients Enrolled |
1936
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| Actual Number of Sites Enrolled |
156
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| Patient Follow-up Rate |
Of the 1936 patients who underwent a Navitor procedure, 1887 patients (97.5%) had a discharge visit completed. Patients alive that have reached the start of the follow-up window: 1717/1854 patients (92.6%) completed their 30-day visit; and 226/790 (28.6%) completed their 1-year visit and 564 do not have data available yet.
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