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Clinical Trial Summary

The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up. The study will be a single arm, prospective, multi-center, non-blinded and non-randomized study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that completed the 2-year follow-up in the HeartMate 3 CE Mark study.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Advanced Refractory Left Ventricular Heart Failure
  • Heart Failure

NCT number NCT03022461
Study type Observational
Source Abbott Medical Devices
Contact
Status Completed
Phase
Start date June 23, 2014
Completion date December 12, 2019

See also
  Status Clinical Trial Phase
Completed NCT02224755 - MOMENTUM 3 IDE Clinical Study Protocol N/A
Completed NCT04548128 - Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
Completed NCT02170363 - HeartMate 3™ CE Mark Clinical Investigation Plan N/A
Completed NCT03982979 - MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS
Completed NCT02892955 - MOMENTUM 3 Continued Access Protocol N/A