CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,001 enrolled
Drug / intervention
Portico™ Valve, Portico Delivery System(s) and Loading System(s) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03752866
NCT03752866N/ACompleted
CompareCT.gov

CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence

Abbott Medical Devices·interventional·Posted Nov 26, 2018·Updated Oct 21, 2024

In Brief

A clinical study evaluating Portico™ Valve, Portico Delivery System(s) and Loading System(s) and Portico™ Valve, FlexNav Delivery System(s) and Loading System(s) for Symptomatic Degenerative Aortic Stenosis and Severe Aortic Stenosis. Completed, enrolled 1,001 participants across 28 sites in 9 countries.

Detailed Summary

The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSymptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CountriesAustralia, Belgium, Czechia, Germany, Italy, Poland, Spain, Switzerland, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 26, 2018
Enrollment StartOct 25, 2018
Primary CompletionNov 2, 2021
Study CompletionJul 28, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.6 years ago

Interventions

Portico™ Valve, Portico Delivery System(s) and Loading System(s)device

Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system.

Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)device

Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems.