NCT02224755

MOMENTUM 3 IDE Clinical Study Protocol

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,028 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Refractory Left Ventricular Heart Failure

Interventions

Type	Name	Description
DEVICE	HeartMate 3 LVAS	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
DEVICE	HeartMate II LVAS	Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure

Timeline

• Start date: 2014-09-02
• Primary completion: 2018-09-28
• Completion: 2019-03-26
• First posted: 2014-08-25
• Last updated: 2022-06-27
• Results posted: 2019-11-20

Locations

69 sites across 1 country: United States