At a glance
ClinicalIndex Comparison RecordN/ACompleted· 20 enrolled
Drug / intervention
MDT-2111 TAVI 23 mmdevice
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.
Medtronic MDT-2111 CoreValve Japan 23mm Study
In Brief
A clinical study evaluating MDT-2111 TAVI 23 mm for Aortic Valve Stenosis. Completed, enrolled 20 participants across 4 sites.
Detailed Summary
The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for surgical operation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedJul 2012
Primary CompletionFeb 2014
Study CompletionSep 2019
TodayJul 2026
First PostedJul 6, 2012
Enrollment StartJul 1, 2012
Primary CompletionFeb 1, 2014
Study CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.0 years ago
Interventions
MDT-2111 TAVI 23 mmdevice
Device: 23 mm MDT-2111 System for Transcatheter Aortic Valve Implantation (TAVI) Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.