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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P190023 / PAS001 |
| Date Original Protocol Accepted |
09/17/2021
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| Date Current Protocol Accepted |
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| Study Name |
Cont f/u of the PORTICO IDE cohorts
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| Device Name |
Portico Transcatheter Aortic Valve Implantation System
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| Clinical Trial Number(s) |
NCT02000115
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent 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 study objective is to characterize the acute safety and effectiveness of the Portico 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, randomized controlled trial (RCT) that also included non-randomized arms: Roll-in Registry, FlexNav Study, Extreme Risk Registry and Valve-in-Valve (ViV) Registry.
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| Study Population |
Patients with symptomatic, severe aortic stenosis who are considered high or extreme surgical risk.
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| Sample Size |
All living subjects enrolled under the IDE Portico approval studies, including all analysis, registry, roll-in, and continued access cohorts
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| 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 Kansas City Cardiomyopathy Questionnaire (KCCQ), and
· hemodynamic performance metrics by echocardiography.
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| Follow-up Visits and Length of Follow-up |
5 years
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| Interim or Final Data Summary |
| Interim Results |
Safety Results
At 60 months – RCT Portico, RCT CAV, Roll-in, and Extreme Risk:
All-cause mortality: 51.8% (RCT Portico), 48.2% (RCT CAV), 55.3% (Roll-in), 100% (Extreme Risk)
All stroke: 11.5% (RCT Portico), 12.9% (RCT CAV), 18.4% (Roll-in), 0.0% (Extreme Risk)
Myocardial infarction: 9.7% (RCT Portico), 8.8% (RCT CAV), 11.3% (Roll-in), 12.5% (Extreme Risk)
Reintervention: 3.8% (RCT Portico), 1.2% (RCT CAV), 1.2% (Roll-in), 0.0% (Extreme Risk)
Rehospitalization for valve-related symptoms: 13.6% (RCT Portico), 12.0% (RCT CAV), 21.0% (Roll-in), 19.2% (Extreme Risk)
New permanent pacemaker implantation: 35.9% (RCT Portico), 20.2% (RCT CAV), 29.5% (Roll-in), 11.1% (Extreme Risk)
New-onset atrial fibrillation: 18.5% (RCT Portico), 15.8% (RCT CAV), 16.9% (Roll-in), 9.1% (Extreme Risk)
At 48 months – FlexNav and CAP:
All-cause mortality: 34.4% (FlexNav), 44.9% (CAP)
All stroke: 7.5% (FlexNav), 19.2% (CAP)
Myocardial infarction: 7.3% (FlexNav), 7.5% (CAP)
Reintervention: 1.5% (FlexNav), 0.0% (CAP)
Rehospitalization for valve-related symptoms: 10.4% (FlexNav), 15.9% (CAP)
New permanent pacemaker implantation: 19.7% (FlexNav), 36.1% (CAP)
New-onset atrial fibrillation: 16.5% (FlexNav), 13.2% (CAP)
Effectiveness Results
At 60 months – RCT Portico and RCT CAV:
New York Heart Association (NYHA) functional classification (% in Class III/IV): 6.5% (RCT Portico), 11.4% (RCT CAV)
Kansas City Cardiomyopathy Questionnaire (KCCQ) score: 73.2 +/-21.7 (RCT Portico), 74.5 +/-23.8 (RCT CAV)
Transvalvular mean gradient: 7.49 +/-4.66 mmHg (RCT Portico), 9.23 +/-6.40 mmHg (RCT CAV)
Aortic valve area: 1.80 +/-0.46 cm2 (RCT Portico), 1.70 +/-0.50 cm2 (RCT CAV)
Greater than or equal to Moderate Paravalvular Leak: 2.4% (RCT Portico), 0.0% (RCT CAV)
At 48 months – FlexNav cohort:
New York Heart Association (NYHA) functional classification (% in Class III/IV): 16.1% (FlexNav)
Kansas City Cardiomyopathy Questionnaire (KCCQ) score: 68.8 +/-22.5 (FlexNav)
Transvalvular mean gradient: 6.77 +/-2.66 mmHg (FlexNav)
Aortic valve area: 1.73+/-0.39 cm2 (FlexNav)
Greater than or equal to Moderate Paravalvular Leak: 0.0% (FlexNav)
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| Actual Number of Patients Enrolled |
Total: 1242 subjects enrolled in the pivotal IDE trial:
Randomized (RCT) Portico group (n=381), Randomized (RCT) control (CAV) group (n=369) CAP Study
(n=148),
FlexNav Study (n=134; total includes 34 roll-ins), Roll-In Registry (n=197)
Extreme Risk Registry (n=13).
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| Actual Number of Sites Enrolled |
Sites enrolled: 65 US sites, 5 AUS sites
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| Patient Follow-up Rate |
Total Duration (excluding deaths and withdrawals):
RCT Portico: 95.7%
RCT CAV: 95.8%
CAP: 95.6%
FlexNav: 97.5%;
Roll-in: 96.8%;
Extreme Risk: 80.2%;
At 60 months (excluding deaths and withdrawals):
RCT Portico: 92.8%
RCT CAV: 94.8%
CAP: 86.0%
FlexNav: 89.2%;
Roll-in: 93.8%;
Extreme Risk: 0.0%
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