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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 |
01/13/2023
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| Study Name |
Registry-Based Real-World Use Surveillance Study
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| Device Name |
Navitor Transcatheter Aortic Valve Implantation System; Navitor Transcatheter Aortic Heart Valve; FlexNav Delivery System; Navitor Loading System
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| Clinical Trial Number(s) |
NCT04011722
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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 |
Adult: At least 22 yrs
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| 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 = 2.9%
o All stroke = 2.7%
o Life threatening or major bleeding = 0.6%
o New requirement for dialysis = 0.4%
o New permanent pacemaker implantation = 17.2%
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 = 1.8%
o Minor vascular complications = 4.0%
o Kansas City Cardiomyopathy Questionnaire (KCCQ) – 75.9 (51.8 pre-procedure)
• 1-year endpoints:
o All-cause mortality = 12.6%
o All stroke = 4.5%
o Life threatening or major bleeding = 2.8%
o New requirement for dialysis = 0.9%
o New permanent pacemaker implantation = 19%
o Peri-procedural myocardial infarction = 1.9%
o Reintervention – Aortic valve related = 0.6%
o Neurological (TIA / non-stroke) events = 0.9%
o Major vascular complications = 1.9%
o Minor vascular complications = 4.1%
o Kansas City Cardiomyopathy Questionnaire (KCCQ) – 80.6 (51.8 pre-procedure)
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| Actual Number of Patients Enrolled |
3380
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| Actual Number of Sites Enrolled |
203
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| Patient Follow-up Rate |
Of the 3380 patients who underwent a Navitor procedure, 3301 patients (97.7%) had a discharge visit completed. Patients alive that have reached the start of the follow-up window: 3061/3229 patients (94.8%) completed their 30-day visit; and 1513/2946 (51.3%) completed their 1-year visit and 1433 do not have data available yet.
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