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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P190023 S013/ PAS001 |
| Date Original Protocol Accepted |
09/15/2023
|
| Date Current Protocol Accepted |
|
| Study Name |
Cont f/u of the IDE Portico NG Titan Cohort
|
| 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 Titan 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 – Titan cohort, including all analysis and roll-in subjects.
|
| 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 |
| Interim Results |
Safety Results
At 12 months:
All-cause mortality: 8.3%
All-cause and disabling stroke: 8.5% (all); 1.4% (disabling)
Life-threatening and Major bleeding events: 2.9% (life-threatening); 9.9% (major)
Stage 2 or 3 acute kidney injury (AKI): 0.0%
Major vascular complications: 4.1%
Myocardial infarction: 4.3%
Re-operation for valve-related dysfunction: 1.4%
Rehospitalization for valve-related symptoms: 2.8%
New permanent pacemaker implantation: 38.6%
New-onset atrial fibrillation: 4.1%
Effectiveness Results
At 12 months:
Mean aortic valve gradient: 5.5+/-3.0mmHg
Effective orifice area (EOA): 2.5+/-0.5
Paravalvular Leak (moderate/severe): 0.0%
New York Heart Association (NYHA) functional class (Class III/IV): 3.2%
Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36): 42.4+/-9.4 (Physical, PCS), 55.1+/-7.3 (Mental, MCS)
|
| Actual Number of Patients Enrolled |
73 subjects implanted with the Navitor Titan valve
|
| Actual Number of Sites Enrolled |
18 sites in the United States, Australia, Denmark, Italy, and United
Kingdom (12 US, 6 OUS)
|
| Patient Follow-up Rate |
98.5% (12 months); 100% (24 months).
|
