CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Portico Valve and FlexNav™ Delivery Systemdevice
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/NCT03724812
NCT03724812N/ACompleted
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Assessment of the Abbott FlexNav™ Delivery System for Portico Transcatheter Aortic Valve Implantation in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis

Abbott Medical Devices·interventional·Posted Oct 30, 2018·Updated Nov 24, 2021

In Brief

A clinical study evaluating Portico Valve and FlexNav™ Delivery System for Symptomatic Severe Aortic Stenosis. Completed, enrolled 46 participants across 6 sites in 4 countries.

Detailed Summary

The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic stenosis patients who are considered of high or extreme risk for surgical aortic valve replacement. Data from the study will be used to support CE Mark of the FlexNav™ Delivery System and Loading System in Europe.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSymptomatic Severe Aortic Stenosis
CountriesDenmark, Italy, Switzerland, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 30, 2018
Enrollment StartFeb 26, 2019
Primary CompletionJan 14, 2020
Study CompletionFeb 10, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.7 years ago

Interventions

Portico Valve and FlexNav™ Delivery Systemdevice

Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Portico valve and second-generation FlexNav Delivery system via a transfemoral access approach