MOMENTUM 3 IDE Clinical Study Protocol — HM3™

Advanced Refractory Left Ventricular Heart Failure Clinical Trial

Official title:
Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol

Status Completed

Clinical Trial 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.

Clinical Trial Description

The HM3 LVAS is intended to provide hemodynamic support in patients with advanced, refractory left ventricular heart failure; either for short term support, such as a bridge to cardiac transplantation (BTT) or myocardial recovery, or as long term support, such as destination therapy (DT). The HM3 is intended for use inside or outside the hospital. ;

Study Design

Related Conditions & MeSH terms

Advanced Refractory Left Ventricular Heart Failure
Heart Failure

Clinical Trial Details

NCT number	NCT02224755
Study type	Interventional
Source	Abbott Medical Devices
Contact
Status	Completed
Phase	N/A
Start date	September 2, 2014
Completion date	March 26, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04548128` - Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
Completed	`NCT03022461` - HeartMate 3 CE Mark Study Long Term Follow-up
Completed	`NCT02170363` - HeartMate 3™ CE Mark Clinical Investigation Plan	N/A
Completed	`NCT03982979` - MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS
Completed	`NCT02892955` - MOMENTUM 3 Continued Access Protocol	N/A