CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 934 enrolled
Drug / intervention
EDWARDS INTUITY valvedevice
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/NCT01700439
NCT01700439N/ACompleted
CompareCT.gov

Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent

Edwards Lifesciences·interventional·Posted Oct 4, 2012·Updated May 19, 2023

In Brief

A clinical study evaluating EDWARDS INTUITY valve for Aortic Valve Stenosis and 3 related conditions. Completed, enrolled 934 participants across 29 sites.

Detailed Summary

The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 4, 2012
Enrollment StartSep 26, 2012
Primary CompletionMay 26, 2021
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 13.7 years ago

Interventions

EDWARDS INTUITY valvedevice

Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.