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

Abbott Medical Devices101 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

101

Conditions

Heart Failure

Interventions

Hemodynamic management using CardioMEMS HF SystemDEVICE

Using the CardioMEMS HF System, clinicians will treat to target PA pressure ranges

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 PA 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.)

Locations (23)

Scripps Health

La Jolla, California, United States

Outcomes

Primary Outcomes

Six Minute Hall Walk (6MHW) Distance

Change in 6MHW distance compared to baseline. The six-minute hall walk (6MHW) test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.

Time frame: Six Months

Data from ClinicalTrials.gov

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