At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,127 enrolled
Drug / intervention
Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)device
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.
Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study
In Brief
An observational study evaluating Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum) for Symptomatic Aortic Stenosis. Completed, enrolled 1,127 participants across 60 sites in 12 countries.
Detailed Summary
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices. The purpose of the addendum is to collect post-market clinical evidence on valve performance and procedural outcomes associated with the Evolut FX Device.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSymptomatic Aortic Stenosis
CountriesAustralia, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartSep 2019
Primary CompletionDec 2023
Study CompletionNov 2024
TodayJul 2026
First PostedSep 16, 2019
Enrollment StartSep 16, 2019
Primary CompletionDec 15, 2023
Study CompletionNov 13, 2024
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 6.8 years ago
Interventions
Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)device
Aortic valve replacement