CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,028 enrolled
Drug / intervention
HeartMate 3 LVAS +1 moredevice
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/NCT02224755
NCT02224755N/ACompleted
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Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol

Abbott Medical Devices·interventional·Posted Aug 25, 2014·Updated Jun 27, 2022

In Brief

A clinical study evaluating HeartMate 3 LVAS and HeartMate II LVAS for Advanced Refractory Left Ventricular Heart Failure. Completed, enrolled 1,028 participants across 69 sites.

Detailed Summary

The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Refractory Left Ventricular Heart Failure
CountriesUnited States
CollaboratorsThoratec Corporation

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 25, 2014
Enrollment StartSep 2, 2014
Primary CompletionSep 28, 2018
Study CompletionMar 26, 2019
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 11.9 years ago

Interventions

HeartMate 3 LVASdevice

Implantation of HeartMate 3 LVAD to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure

HeartMate II LVASdevice

Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure