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

Completed

Conditions studied: Heart Failure

In brief

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

Key facts

Study ID

NCT03247829

Run by

Abbott Medical Devices

People needed

101

Starts

2017-08-24

Expected to finish

2020-06-30

Last updated by the study team

2024-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 PA Sensor must be implanted within 72 hours of consent (Group B)
• Signed an informed consent form and agreed to provide access to patient and device data (including CardioMEMS Merlin.net data)
• No connectivity or transmission problems with CardioMEMS
• On HeartMate LVAD support for at least 3 months
• Age ≥ 18 years

You may not qualify if…

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

Where it is running

• Scripps Health — La Jolla, California, United States
• USC University Hospital — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• San Diego Cardiac — San Diego, California, United States
• California Pacific Medical Center - Van Ness Campus — San Francisco, California, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• The Nebraska Medical Center — Omaha, Nebraska, United States
• North Shore University Hospital — Manhasset, New York, United States
• New York-Presbyterian/Columbia University Medical Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• St. Francis Hospital — Roslyn, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• University of North Carolina — Raleigh, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio Sate University — Columbus, Ohio, United States
• Providence Heart and Vascular Institute — Portland, Oregon, United States
• Palmetto Health Richland — Columbia, South Carolina, United States
• The Methodist Hospital — Houston, Texas, United States
• University of Utah Hospital — Salt Lake City, Utah, United States
• Aurora Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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