Skip to main content
OpenTrials
Completed

NCT Number: NCT03982979

MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Refractory Left Ventricular Heart Failure

Sex eligibility

All sexes

Study type

Observational

Primary location

Abbott

Burlington, Massachusetts, 01803, United States

About this study

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if subjects receive a device exchange to any device other than HM II or HM3, at any time during the study, they will be withdrawn from the study and will not be followed.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject or legal representative has signed Informed Consent Form (ICF)
  • Subject was enrolled in the MOMENTUM 3 IDE trial and was ongoing at the 2-year follow-up visit

Exclusion criteria

  • Subject or legal representative does not consent to extended data collection after the MOMENTUM 3 IDE trial 2-year follow-up visit

Special Circumstance:

  • Sites with patients who expired after the MOMENTUM 3 IDE trial 2-year follow-up visit but prior to signing the ICF for this PAS will obtain IRB approval to collect only the date and cause of death

Treatment and study plan

HM3 LVAS

Device

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

Primary outcomes

  1. Survival

    Time frame: up to 5 years post-implant

    Composite of Survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump

  2. Subject outcomes and survival

    Time frame: up to 5 years post-implant

    Subject outcomes and survival which includes death, transplant, explant, or a pump exchange to any device other than HM II or HM3

  3. Bleeding (including GI bleeding)

    Time frame: up to 5 years post-implant

    Frequency and incidence of bleeding (including GI bleeding)

  4. Major infection

    Time frame: up to 5 years post-implant

    Frequency and incidence of major infection

  5. Hemolysis

    Time frame: up to 5 years post-implant

    Frequency and incidence of hemolysis

  6. Device thrombosis

    Time frame: up to 5 years post-implant

    Frequency and incidence of device thrombosis

  7. Neurological dysfunction

    Time frame: up to 5 years post-implant

    Frequency and incidence of neurological dysfunction

  8. Device related SAEs

    Time frame: up to 5 years post-implant

    Frequency and incidence of device related SAEs

  9. NYHA

    Time frame: up to 5 years post-implant

    New York Heart Association (NYHA) classification

  10. 6MWD

    Time frame: up to 5 years post-implant

    Six-minute walk distance (6MWD)

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 12, 2019
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.