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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)

COVID-19 update:

In response to the COVID pandemic, Scripps Health has temporarily suspended enrollment for all clinical trials. Exceptions will exist for trials with curative intent, life-saving treatment or when no standard of care exists. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

Trial ID:
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 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.)

Why isn't this trial accepting new patients?

The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting

How else can Scripps help me?

We have a broad range of physician expertise and specialized medical services available. You can find a doctor online, call 1-800-SCRIPPS (1-800-727-4777) for personal help, or see related Scripps services.

How can I find trials that are accepting new participants?

For more information, see a list of trials that are recruiting, or call the clinical research office at 858-648-6402 for help.