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ADVANCE Direct Aortic Study

NCT01676727 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2018-09-19

Study results available
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Summary

This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.

Conditions

  • Aortic Stenosis
  • Valvular Heart Disease

Interventions

DEVICE

CoreValve aortic valve

Implantation of CoreValve aortic valve via direct aortic approach

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Neil Moat, M.D. · The Royal Brompton Hospital

  • Giuseppe Bruschi, M.D. · Azienda spedaliera Niguarda Ca' Granda Milano

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-04-30
Completion
2015-08-31

Countries

  • Czechia
  • France
  • Germany
  • Italy
  • 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 NCT01676727 on ClinicalTrials.gov