Heart Failure Clinical Trial
Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMSâ„¢
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
Full Description
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
Eligibility Criteria
Inclusion Criteria:
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)
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
Exclusion Criteria:
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.)
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 22 Locations for this study
La Jolla California, 92037, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
San Diego California, 92123, United States
San Francisco California, 94109, United States
Lexington Kentucky, 40536, United States
Ann Arbor Michigan, 48109, United States
Minneapolis Minnesota, 55455, United States
Omaha Nebraska, 68105, United States
Manhasset New York, 11030, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Roslyn New York, 11576, United States
Chapel Hill North Carolina, 27607, United States
Raleigh North Carolina, 27607, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97225, United States
Columbia South Carolina, 29203, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84132, United States
Milwaukee Wisconsin, 53215, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.