Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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

Official Title

Investigation to Optimize Hemodynamic Management of HeartMate II™ Left Ventricular Assist Device Patients Using the CardioMEMS™ Pulmonary Artery Pressure Sensor in Advanced Heart Failure

Details

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

Keywords

Heart Failure CardioMEMS Left Ventricular Assist Device Hemodynamic Management Hemodynamic management using CardioMEMS

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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.)

Locations

  • Ronald Reagan UCLA Medical Center
    Los Angeles California 90095 United States
  • Scripps Health
    La Jolla California 92037 United States
  • San Diego Cardiac
    San Diego California 92123 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT03247829
Study Type
Observational
Last Updated