At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,685 enrolled
Drug / intervention
HeartMate 3 LVASdevice
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.
Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol: Post-Approval Continued Follow-up
In Brief
A clinical study evaluating HeartMate 3 LVAS for Advanced Refractory Left Ventricular Heart Failure. Completed, enrolled 1,685 participants across 69 sites.
Detailed Summary
The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
Enrollment StartAug 2016
First PostedSep 2016
Primary CompletionDec 2020
Study CompletionMar 2021
TodayJul 2026
First PostedSep 8, 2016
Enrollment StartAug 1, 2016
Primary CompletionDec 1, 2020
Study CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 9.8 years ago
Interventions
HeartMate 3 LVASdevice
Implantation of HeartMate 3 LVAD to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the MOMENTUM 3 IDE Study.