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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 |
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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: >21
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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
• 99.0% of patients had a successful implant.
• The mean Procedure Time was 69.9 ± 39.2 minutes.
• Sixty-four patients (12.4%) required concomitant procedures.
• There was one (0.2%) conversion to open heart surgery and seventeen (3.3%) valve-in-valve implantation.
• One (1) patient was implanted with two (2) Navitor valves. Four (4) patients were not implanted.
• 94.2% of patients were discharged home. The mean length of hospital stay was 2.5 days.
• 30-day endpoints:
o All-cause mortality = 3.8%
o All stroke = 1.4%
o Life threatening or major bleeding = 0.8%,
o New permanent pacemaker implantation = 16.6%
o New requirement for dialysis = 0.6%
o Peri-procedural myocardial infarction = 0.4%
o Reintervention – Aortic valve related = 0.4%
o Neurological (TIA / non-stroke) events = 0.0%
o Major vascular complications = 2.3%
o Minor vascular complications = 4.7%
• 1 year endpoints:
o All-cause mortality = 5.4%
o All stroke = 1.6%
o Life threatening or major bleeding = 1.0%,
o New permanent pacemaker implantation = 16.6%
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| Actual Number of Patients Enrolled |
515
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| Actual Number of Sites Enrolled |
68
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| Patient Follow-up Rate |
Of the 515 patients who underwent a Navitor procedure and remained alive at the follow-up window, 500 (100%) had a discharge visit completed, 473 patients (96.5%) completed their 30-day visit, and 14 (6.7%) have completed their 1-year visit. For 1-year follow-up, of the 515 patients: 29 have died and 275 have not yet reached the start of window. Additional 1-year results are pending and 2-year or longer follow-up times are not available with the TVT Registry data extract schedule.
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