CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 634 enrolled
Drug / intervention
Medtronic CoreValve® Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT01015612N/ACompleted
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CoreValve® System Australia/New Zealand Clinical Study

Medtronic Cardiovascular·interventional·Posted Nov 18, 2009·Updated Nov 12, 2019

In Brief

A clinical study evaluating Medtronic CoreValve® System for Aortic Valve Stenosis. Completed, enrolled 634 participants across 10 sites in 2 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis
CountriesAustralia, New Zealand
CollaboratorsMedtronic Australasia

Timeline

N/ACompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 18, 2009
Enrollment StartAug 1, 2008
Primary CompletionOct 1, 2014
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 16.6 years ago

Interventions

Medtronic CoreValve® Systemdevice

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