NCT03982979

MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS

MOMENTUM 3 Pivotal Cohort Extended Follow-up Post-Approval Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 295 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The study will be a prospective, multi-center, non-blinded, controlled study, intended to evaluate the extended use of the HM3 LVAS compared to the HMII LVAS in those patients that are ongoing at the 2-year follow-up in the MOMENTUM 3 IDE trial. A total of 1028 subjects were enrolled in the MOMENTUM 3 IDE trial. Approximately 533 subjects were ongoing support at the 2-year follow-up and are eligible for enrollment in this PAS. This study will be conducted at sites that participated in the MOMENTUM 3 IDE trial which will include up to 69 centers in the United States.

Detailed description

Subjects on LVAD support after the MOMENTUM 3 IDE trial 2-year follow-up visit can be enrolled after providing consent to extended follow-up. They will be followed to 5 years post-implant or outcome (transplant, explant or death), whichever occurs first. Subjects who have been transplanted, their device exchanged to another pump other than a HM II or HM3, or explanted after the MOMENTUM 3 IDE trial 2-year follow-up but prior to providing consent for this PAS can also be enrolled. Data between the 2-year follow-up visit and the date of pump exchange, explant, or transplant will be retrospectively collected. Once enrolled, if subjects receive a device exchange to any device other than HM II or HM3, at any time during the study, they will be withdrawn from the study and will not be followed. In the event that a subject expired prior to providing consent, IRB approval will be obtained to collect the date and cause of death.

Conditions

• Advanced Refractory Left Ventricular Heart Failure

Interventions

Type	Name	Description
DEVICE	HM3 LVAS	HeartMate® 3 (HM3) Left Ventricular Assist System (LVAS)

Timeline

• Start date: 2019-06-20
• Primary completion: 2021-09-08
• Completion: 2021-09-08
• First posted: 2019-06-12
• Last updated: 2022-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study