A Post-Approval Study of the Pivotal Cohort Extended Follow-Up for MOMENTUM 3

Overview

About this study

The primary purpose of this study is to report the composite endpoint of survival to transplant, recovery, or 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 HM3 or HMII LVAS in the MOMENTUM 3 IDE trial and are ongoing at the 2-year follow-up.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Stulak, M.D.

Open for enrollment

Contact information:

Peggy Gruhlke R.N.

(507)255-4151

Gruhlke.Peggy@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20467358

Mayo Clinic Footer