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| General |
| Study Status |
Completed |
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: At least 22 yrs
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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 |
| 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: 96%
FlexNav: 97.5%;
Roll-in: 96.8%;
Extreme Risk: 80.2%;
At 60 months (excluding deaths and withdrawals):
RCT Portico: 93.5%
RCT CAV: 94.8%
CAP: 95.6%
FlexNav: 94.1%;
Roll-in: 93.8%;
Extreme Risk: 0.0%
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| Final Safety Findings |
At 60 months – RCT Portico, RCT CAV, FlexNav, Roll-in and CAP:
All-cause mortality: 51.7% (RCT Portico), 48.2% (RCT CAV), 46.4% (FlexNav), 55.4% (Roll-in), 54.6% (CAP)
All stroke: 11.5% (RCT Portico), 12.9% (RCT CAV), 10.6% (FlexNav), 18.4% (Roll-in), 19.2% (CAP)
Myocardial infarction: 9.7% (RCT Portico), 8.8% (RCT CAV), 10.6% (FlexNav), 11.3% (Roll-in), 9.3% (CAP)
Reintervention: 3.8% (RCT Portico), 1.2% (RCT CAV), 1.5% (FlexNav), 1.2% (Roll-in), 1.9% (CAP)
Rehospitalization for valve-related symptoms: 13.6% (RCT Portico), 12.0% (RCT CAV), 10.3% (FlexNav), 21.0% (Roll-in), 15.9% (CAP)
New permanent pacemaker implantation: 36.3% (RCT Portico), 20.6% (RCT CAV), 19.7% (FlexNav), 29.5% (Roll-in), 36.1% (CAP)
New-onset atrial fibrillation: 18.5% (RCT Portico), 15.8% (RCT CAV), 21% (FlexNav), 16.9% (Roll-in), 15.2% (CAP)
At 48 months – Extreme Risk:
All-cause mortality: 43.4% (100% at 60 months)
All stroke: 0.0%
Myocardial infarction: 12.5%
Reintervention: 0.0%
Rehospitalization for valve-related symptoms: 19.2%
New permanent pacemaker implantation: 11.1%
New-onset atrial fibrillation: 9.1%
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| Final Effect Findings |
At 60 months – RCT Portico, RCT CAV, FlexNav:
New York Heart Association (NYHA) functional classification (% in Class III/IV): 6.5% (RCT Portico), 11.4% (RCT CAV), 11.1% (FlexNav)
Kansas City Cardiomyopathy Questionnaire (KCCQ) score: 73.2 +/- 21.7 (RCT Portico), 74.5 +/- 23.8 (RCT CAV), 70.2 +/- 21.4 (FlexNav)
Transvalvular mean gradient: 7.6 +/- 4.7 mmHg (RCT Portico), 9.3 +/- 6.5 mmHg (RCT CAV), 5.6 +/- 2.6 mmHg (FlexNav)
Aortic valve area: 1.79 +/- 0.47 cm2 (RCT Portico), 1.69 +/- 0.50 cm2 (RCT CAV), 1.92 +/- 0.48 cm2 (FlexNav)
Greater than or equal to Moderate Paravalvular Leak: 2.4% (RCT Portico), 0.0% (RCT CAV), 3.0% (FlexNav)
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| Study Strengths & Weaknesses |
This continued follow-up study provides longer-term data (through 5 years) on the safety and effectiveness of the Portico valve in patients with severe symptomatic aortic stenosis at high or greater surgical risk. Generally, outcomes suggest that safety and effectiveness is maintained through 5 years post procedure, with meaningful improvement in quality of life outcomes and hemodynamic performance. It should be noted that some subjects withdrew or were lost to follow-up in this study. Incomplete follow-up may also lead to biased longer-term results.
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| Recommendations for Labeling Changes |
Complete longer-term follow-up data warrants inclusion into the labeling for the device and should be informative to clinicians and patients regarding the longer-term benefit risk profile for the device.
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