Principal Investigator: Craig Selzman
Keywords: Mechanical Circulatory Support , LVAD , VAD , MCS , Advanced Heart Failure , Cardiology Department: Cardiothoracic Division
IRB Number: 00122672
Specialty: Cardiology, Transplant Surgery, Cardiothoracic Surgery, Cardiology
Sub Specialties: Heart Failure, Cardiac Mechanical Support, Heart Transplant
Recruitment Status: Not yet recruiting

Contact Information

Ashley Elmer
ashley.elmer@hsc.utah.edu
801-585-6775

Brief Summary

Primary objective

The main objective of this Post-Approval Study (PAS) is to report the composite endpoint of survival to transplant, recovery, or Left Ventricular Assist Device (LVAD) support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump at 5-years post-implant in subjects who were implanted with the HeartMate 3 (HM3) or HeartMate II (HMII) LVAS in the MOMENTUM 3 IDE trial and are ongoing at the 2-year follow-up.

Study Endpoints

There are 10 endpoints in this study:

  1. Composite endpoint of survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump over time
  2. Subject outcomes and survival over time
  3. Frequency and incidence of bleeding (including GI bleeding)
  4. Frequency and incidence of major infection
  5. Frequency and incidence of hemolysis
  6. Frequency and incidence of device thrombosis
  7. Frequency and incidence of neurological dysfunction
  8. Frequency and incidence of device related SAEs
  9. New York Heart Association (NYHA) classification
  10. Six-minute walk distance (6MWD)

Inclusion Criteria

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

In the event that a subject expired prior to providing consent, IRB approval will be obtained to collect the date and cause of death. The one patient eligible for this study is deceased so IRB approval is needed to send those two data points to the sponsor.

Exclusion Criteria

Exclusion Criteria

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