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MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS

NCT03982979 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 295

Last updated 2022-06-24

No results posted yet for this study

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.

Conditions

  • Advanced Refractory Left Ventricular Heart Failure

Interventions

DEVICE

HM3 LVAS

HeartMate® 3 (HM3) Left Ventricular Assist System (LVAS)

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Marie-Elena Brett, PhD · Abbott

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2021-09-08
Completion
2021-09-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03982979 on ClinicalTrials.gov