CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,453 enrolled
Drug / intervention
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) +1 moredevice
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.

Search/NCT01240902
NCT01240902N/ACompleted
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Medtronic CoreValve® U.S. Pivotal Trial

Medtronic Cardiovascular·interventional·Posted Nov 15, 2010·Updated Oct 25, 2022

In Brief

A clinical study evaluating Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) and Surgical Aortic Valve Replacement (SAVR) for Severe Aortic Stenosis. Completed, enrolled 1,453 participants across 45 sites.

Detailed Summary

The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Aortic Stenosis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 15, 2010
Enrollment StartDec 10, 2010
Primary CompletionAug 1, 2014
Study CompletionMay 15, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.6 years ago

Interventions

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)device

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Surgical Aortic Valve Replacement (SAVR)device

Surgical Aortic Valve Replacement (SAVR)