INvesTigation to OptimizE Hemodynamic Management of HeartMate II™ Left VentricuLar Assist DEvice Patients using the CardioMEMS™ Pulmonary ArTery Pressure Sensor in Advanced Heart Failure (INTELLECT 2-HF)

Trial ID:
IRB-17-7102
Thomas Heywood
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions

Inclusion Criteria:

  • 1. Subject has CardioMEMS HF PA Sensor and a commercially-approved HeartMate LVAD (Group A) OR Subject has commercially-approved HeartMate LVAD, is experiencing NYHA class III symptoms, and has had a previous HF hospitalization and meets FDA indications for CardioMEMS. The CardioMEMS sensor must be implanted within 72 hours of consent (Group B)
  • 2. Signed an informed consent form and agreed to provide access to patient and device data (including CardioMEMS Merlin.net data)
  • 3. No connectivity or transmission problems with CardioMEMS
  • 4. On HeartMate LVAD support for at least 3 months
  • 5. Age ≥ 18 years

Exclusion Criteria:

  • 1. Current participation in an investigation that is likely to confound study results or affect study outcome
  • 2. Current participation in the MOMENTUM3 IDE Clinical trial and has not completed the two year follow-up for that trial
  • 3. Inability to perform 6MHW test due to conditions other than heart failure (e.g. severe arthritis, orthopedic issues, amputation etc.)

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