CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Tendyne Mitral Valve Systemdevice
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.

Search/NCT03539458
NCT03539458N/ACompleted
CompareCT.gov

Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification

Abbott Medical Devices·interventional·Posted May 29, 2018·Updated Nov 18, 2024

In Brief

A clinical study evaluating Tendyne Mitral Valve System for Mitral Regurgitation and 8 related conditions. Completed, enrolled 11 participants across 4 sites.

Detailed Summary

This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Regurgitation, Mitral Insufficiency, Mitral Annular Calcification, Mitral Annulus Calcification, Cardiovascular Diseases, Valve Heart Disease, Heart Valve Diseases, Heart Valve Calcification, Mitral Valve Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 29, 2018
Enrollment StartOct 10, 2018
Primary CompletionNov 29, 2019
Study CompletionJun 18, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.1 years ago

Interventions

Tendyne Mitral Valve Systemdevice

Mitral valve replacement