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Portico TAVI Implant With Transfemoral Delivery System

NCT01493284 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2019-02-04

Study results available
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Summary

The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).

Conditions

  • Symptomatic Aortic Stenosis

Interventions

DEVICE

Transcatheter Aortic Valve Implantation

Placement of the SJM Portico aortic valve with a transfemoral delivery system

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ganesh Manoharan, MD · Royal Victoria Hospital, Belfast

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-10-31
Completion
2016-09-30

Countries

  • Australia
  • Denmark
  • Germany
  • Netherlands
  • 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 NCT01493284 on ClinicalTrials.gov