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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
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| 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
• A single Portico valve was implanted in 99.1% of the patients; 2 patients required a second Portico valve.
• The mean Procedure Time was 67.4 -/+ 34.6 minutes.
• Fourteen patients (6.5%) required concomitant procedures.
• Three (1.4%) valve-in-valve implantations.
• A total of 214 patients were discharged after the procedure.
• 30-days endpoints:
o All-cause mortality = 1.0%
o All stroke = 2.9%
o Life threatening or major bleeding = 1.0%
o New requirement for dialysis = 0.0%
o New permanent pacemaker implantation = 17.2%
o Peri-procedural myocardial infarction = 0.0%
o Reintervention – Aortic valve related = 1.0%
o Neurological (TIA / non-stroke) events = 0.5%
o Major vascular complications = 1.4%
o Minor vascular complications = 4.2%
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| Actual Number of Patients Enrolled |
216
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| Actual Number of Sites Enrolled |
17
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| Patient Follow-up Rate |
Of the 216 patients enrolled, 214 patients have discharge and 30-day follow-up data.
Two (2) patients died post procedure, but prior to discharge.
A total of 16 patients had no follow-up information available for the 30-day follow-up window as of the data cutoff.
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