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