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FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

NCT03417011 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 638

Last updated 2025-09-09

No results posted yet for this study

Summary

Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.

The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)

Transcatheter Aortic Valve Replacement with Medtronic Evolut PRO system

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-26
Primary Completion
2019-03-06
Completion
2024-02-26

Countries

  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Slovenia
  • 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 NCT03417011 on ClinicalTrials.gov