At a glance
ClinicalIndex Comparison RecordN/AActive· 150 enrolled
Drug / intervention
Medtronic TAVR Systemsdevice
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.
Transcatheter Aortic Valve Replacement (TAVR) With Medtronic TAVR System in Patients With Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality With Surgical Aortic Valve Replacement (SAVR)
In Brief
A clinical study evaluating Medtronic TAVR Systems for Bicuspid Aortic Valve. Active but no longer recruiting, targeting 150 participants across 25 sites.
Detailed Summary
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBicuspid Aortic Valve
CountriesUnited States
Collaborators--
Timeline
N/AActive
2019202020212022202320242025202620272028202920302031
First PostedAug 2018
Enrollment StartOct 2018
Primary CompletionNov 2019
TodayJul 2026
Study CompletionDec 2030
First PostedAug 17, 2018
Enrollment StartOct 30, 2018
Primary CompletionNov 13, 2019
Study CompletionDec 1, 2030
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.9 years ago
Interventions
Medtronic TAVR Systemsdevice
Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems