At a glance
ClinicalIndex Comparison RecordN/AActive· 53 enrolled
Drug / intervention
Edwards SAPIEN 3 transcatheter valve, Model 9600TFXdevice
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.
PARTNER 3 Trial - SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve
In Brief
A clinical study evaluating Edwards SAPIEN 3 transcatheter valve, Model 9600TFX for Mitral Valve Insufficiency and 3 related conditions. Active but no longer recruiting, targeting 53 participants across 12 sites in 3 countries.
Detailed Summary
To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure
CountriesAustralia, Brazil, United States
Collaborators--
Timeline
N/AActive
20182019202020212022202320242025202620272028202920302031
First PostedJun 2017
Enrollment StartFeb 2018
Primary CompletionAug 2022
TodayJul 2026
Study CompletionAug 2031
First PostedJun 21, 2017
Enrollment StartFeb 1, 2018
Primary CompletionAug 16, 2022
Study CompletionAug 1, 2031
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.0 years ago
Interventions
Edwards SAPIEN 3 transcatheter valve, Model 9600TFXdevice
Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.