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5 Year Observation of Patients With PORTICO Valves

NCT01802788 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1032

Last updated 2025-02-11

Study results available
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Summary

The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

St Jude Medical Portico replacement aortic valve

PROCEDURE

Transcatheter Aortic Valve Implant

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Francesco Maisano, MD · San Raffaele Hospital

  • Stephen Worthley · St Andrews Hospital

  • Josep Rodes-Cabau · Institut de Cardiologie de Quebec (Hospital Laval)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-16
Primary Completion
2018-09-25
Completion
2022-10-19

Countries

  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Lithuania
  • Netherlands
  • Spain
  • 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 NCT01802788 on ClinicalTrials.gov