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CoreValve™ Evolut R™ FORWARD Study

NCT02592369 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1060

Last updated 2020-04-30

No results posted yet for this study

Summary

Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Medtronic CoreValve™ Evolut R™ System

The Evolut R System is intended for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, to be at high or extreme risk for open heart surgery. The Evolut R TAV treats aortic stenosis by displacing and functionally replacing the dysfunctional native valve with a bioprosthetic valve delivered on a catheter while the heart is still beating, thus avoiding the risks of cardiopulmonary bypass. Its intended performance is to relieve aortic valve stenosis without inducing significant regurgitation, thereby restoring effective aortic valve function.

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Eberhard Grube, Prof. Dr. · University Hospital, Bonn

  • Stephan Windecker, Prof. Dr. · INSELSPITAL, Universitätsspital Bern

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-02-28
Completion
2020-02-06

Countries

  • Australia
  • Belgium
  • Canada
  • Colombia
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Panama
  • Poland
  • Portugal
  • Saudi Arabia
  • South Africa
  • Spain
  • Sweden
  • 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 NCT02592369 on ClinicalTrials.gov