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FlexNav EU CE Mark Study

NCT03724812 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-11-24

Study results available
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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.

Conditions

  • Symptomatic Severe Aortic Stenosis

Interventions

DEVICE

Portico Valve and FlexNav™ Delivery System

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

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Francesco Bedogni, MD · Policlinico San Donato

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-26
Primary Completion
2020-01-14
Completion
2021-02-10

Countries

  • Denmark
  • Italy
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03724812 on ClinicalTrials.gov