MedTrace Logo

CoreValve® System Australia/New Zealand Clinical Study

NCT01015612 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 634

Last updated 2019-11-12

Study results available
· View outcomes & findings →

Summary

To evaluate the performance, efficacy and safety of the percutaneous implantation of the CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve stenosis that have an elevated surgical risk

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Medtronic CoreValve® System

The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk

Sponsors & Collaborators

  • Medtronic Australasia

    collaborator UNKNOWN

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Ian T Meredith, MD · Monash Heart Medical Center

  • Eric Vang · Medtronic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2014-10-31
Completion
2016-09-30

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

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 NCT01015612 on ClinicalTrials.gov