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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P190023 S002/ PAS001 |
| Date Original Protocol Accepted |
01/13/2023
|
| Date Current Protocol Accepted |
|
| Study Name |
Continued F/U of the IDE Portico NG 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 |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study objective is to characterize the acute safety and effectiveness of the Navitor Transcatheter Aortic Heart Valve through 5 years post procedure in patients with symptomatic, severe aortic stenosis who are considered high or greater surgical risk. The study is a prospective, multi-center, single-arm study.
|
| Study Population |
Patients with symptomatic, severe aortic stenosis who are considered high or extreme surgical risk.
|
| Sample Size |
All living subjects enrolled under the IDE Portico NG Approval study, including all analysis, roll-in, and continued access cohorts
|
| Key Study Endpoints |
The safety and effectiveness endpoints include, but are not limited to: all-cause mortality, all-cause and disabling stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, major vascular complications, paravalvular aortic regurgitation, myocardial infarction, re-operation for valve-related dysfunction, rehospitalization for valve-related symptoms or worsening congestive heart failure, new permanent pacemaker implantation, new-onset atrial fibrillation, functional status as evaluated by New York Heart Association (NYHA), health status as evaluated by Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) through 1 year, and hemodynamic performance metrics by echocardiography.
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Total: n = 260 implanted with the Navitor valve
|
| Actual Number of Sites Enrolled |
26 sites in the United States, Australia, Denmark, Italy, and the United Kingdom (19 US, 7 OUS)
|
| Patient Follow-up Rate |
97.9% [12 months]
94.6% [24 months]
|
| Final Safety Findings |
All-cause mortality: 6.6% [12 months], 14.6% [12 months]
All-cause stroke: 5.1% [12 months], 5.9% [24 months]
Disabling stroke: 2.3% [12 months], 2.8% [24 months]
Life-threatening and major bleeding events: 6.6% (life-threatening); 5.0% (major) [12 months]
Stage 2 or 3 acute kidney injury (AKI): 2.3% [12 months]
Major vascular complications: 4.2% [12 months]
Myocardial infarction: 2.8% [12 months], 6.4% [24 months]
Re-operation for valve-related dysfunction: 0.4% [12 months], 0.8% [24 months]
Rehospitalization for valve-related symptoms: 2.7% [12 months], 3.2% [24 months]
New permanent pacemaker implantation: 21.7% [12 months], 23.1% [24 months]
New-onset atrial fibrillation: 5.5% [12 months], 8.1% [24 months]
|
| Final Effect Findings |
Mean aortic valve gradient: 7.6±3.6mmHg [12 months], 7.3±3.3mmHg [24 months]
Effective orifice area (EOA): 2.0±0.5 cm2 [12 months], 2.0±0.5 cm2 [24 months]
Paravalvular Leak (moderate/severe): 0.5% [12 months], 0.6% [24 months]
New York Heart Association (NYHA) functional class (Class III/IV): 2.8% [12 months], 5.3% [24 months]
Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36): 40.2±10.9 (Physical, PCS), 55.3±9.7 (Mental, MCS) [12 months]
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