Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™

The study is an observational, single group study where all participants receive the same
intervention. The study plans to enroll up to 100 patients at 25 US sites. All patients will
have a HeartMate Left Ventricular Assist Device (LVAD) and a CardioMEMS device implanted as
standard of care. After enrollment into the study, the patient will be followed until six
month follow up completion. The objective of this clinical investigation is to understand the
role of hemodynamic monitoring in LVAD patients and:

- Characterize PA pressure measurements with the CardioMEMS HF System in LVAD patients
under different clinical and physiologic conditions

- Characterize the effects of PA pressure on functional status, quality of life, and
hospital readmissions of LVAD patients

- Evaluate target ranges for PA pressure and assess the impact of medication and pump
speed changes on PA pressures

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.)