At a glance
ClinicalIndex Comparison RecordN/ACompleted· 91 enrolled
Drug / intervention
Transcatheter Mitral Valve Replacementdevice
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.
The Safety and Feasibility of the SAPIEN XTTM Transcatheter Heart Valve With NovaFlex and Ascendra Delivery Systems and SAPIEN 3 With Commander Delivery System in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification and Patients With Failing Mitral Surgical Rings or Bioprostheses Who Are Not Candidates for Mitral Valve Surgery.
In Brief
A clinical study evaluating Transcatheter Mitral Valve Replacement for Mitral Valve Disease. Completed, enrolled 91 participants across 15 sites.
Detailed Summary
The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification who are not candidates for standard mitral valve surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Valve Disease
CountriesUnited States
CollaboratorsHenry Ford Hospital
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2015
Enrollment StartFeb 2015
Primary CompletionDec 2018
TodayJul 2026
First PostedFeb 25, 2015
Enrollment StartFeb 25, 2015
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.4 years ago
Interventions
Transcatheter Mitral Valve Replacementdevice
Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.