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Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)

NCT01051518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2019-02-19

Study results available
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Summary

The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptomatic aortic native valve stenosis necessitating valve replacement which are considered poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.

Safety and performance will be evaluated at discharge and at 30 days post-procedure. Valve performance and placement will be followed up at 3 and 6 months post-procedure. Further long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months post-procedure.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Medtronic CoreValve System

Transcatheter Aortic Valve

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • E. Grube, Prof. Dr. · Helios Heart Center Siegburg, Germany

  • G. Schuler, Prof. Dr. · Herzzentrum Universitat Leipzig, Germany

  • R. Bonan, Dr. · Institut de Cardiologie de Montreal, Canada

  • J. Kovac, Dr. · Glenfield Hospital Leicester, UK

  • P. Serruys, Prof. Dr. · Erasmus MC Rotterdam, Netherlands

  • M. Labinaz, Dr. · University of Ottawa Heart Institute, Canada

  • P den Heijer, Dr. · Amphia Hospital Breda, Netherlands

  • M Mullen, Dr. · Royal Brompton & Harefield NHS Trust London, UK

  • W. Tymchak, Dr. · University of Alberta Hospital, Canada

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2009-02-28
Completion
2013-06-30

Countries

  • Canada
  • 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 NCT01051518 on ClinicalTrials.gov