At a glance
ClinicalIndex Comparison RecordN/ACompleted· 25 enrolled
Drug / intervention
Mitral Valve Replacement (MVR) with Sapien3device
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.
Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
In Brief
A clinical study evaluating Mitral Valve Replacement (MVR) with Sapien3 for Mitral Annular Calcification. Completed, enrolled 25 participants across 6 sites.
Detailed Summary
The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at high-risk for mitral valve surgery or deemed inoperable due to the extent of calcification.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Annular Calcification
CountriesUnited States
CollaboratorsEdwards Lifesciences
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartNov 2016
Primary CompletionJan 2023
Study CompletionNov 2023
TodayJul 2026
First PostedJul 12, 2016
Enrollment StartNov 4, 2016
Primary CompletionJan 3, 2023
Study CompletionNov 29, 2023
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 10.0 years ago
Interventions
Mitral Valve Replacement (MVR) with Sapien3device
subjects with surgical MVR with Sapien3