At a glance
ClinicalIndex Comparison RecordN/ACompleted· 516 enrolled
Drug / intervention
Not specified
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.
Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study.
In Brief
An observational study for Aortic Valve Disease and 2 related conditions. Completed, enrolled 516 participants across 27 sites in 9 countries.
Detailed Summary
The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population. The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Denmark, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedJan 2015
Primary CompletionApr 2016
TodayJul 2026
First PostedJan 14, 2015
Enrollment StartJul 1, 2012
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.5 years ago