NCT02892955

MOMENTUM 3 Continued Access Protocol

Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol: Post-Approval Continued Follow-up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,685 (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 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.

Detailed description

Enrollment in the CAP cohort ended shortly after approval for the long-term indication was received from the FDA in October 2018. As a condition of approval, all patients enrolled in the CAP cohort were to complete the 2-year follow-up to fulfil a post-approval study requirement.

Conditions

• Advanced Refractory Left Ventricular Heart Failure

Interventions

Type	Name	Description
DEVICE	HeartMate 3 LVAS	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.

Timeline

• Start date: 2016-08-01
• Primary completion: 2020-12-01
• Completion: 2021-03-01
• First posted: 2016-09-08
• Last updated: 2022-06-27
• Results posted: 2022-03-03

Locations

69 sites across 1 country: United States

Regulatory

• FDA-regulated device study