At a glance
ClinicalIndex Comparison RecordN/ACompleted· 30 enrolled
Drug / intervention
AVJ-514device
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.
A Prospective, Multi-Center, Single-Arm Clinical Evaluation of the AVJ-514 System for the Treatment of Symptomatic Chronic Severe Mitral Regurgitation
In Brief
A clinical study evaluating AVJ-514 for Mitral Stenosis With Insufficiency and 4 related conditions. Completed, enrolled 30 participants across 6 sites.
Detailed Summary
The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart team.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Stenosis With Insufficiency, Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartSep 2015
Primary CompletionJul 2016
Study CompletionMay 2021
TodayJul 2026
First PostedAug 11, 2015
Enrollment StartSep 7, 2015
Primary CompletionJul 1, 2016
Study CompletionMay 31, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.9 years ago
Interventions
AVJ-514device
Patients receiving AVJ-514 device