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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Hemodynamic management using CardioMEMS


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with CardioMEMS and LVAD<br>Patients with CardioMEMS and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS | Device: Hemodynamic management using CardioMEMS<br>* Using the CardioMEMS HF system, clinicians will treat to target PA pressure ranges<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six Minute Hall Walk (6MHW) distance | Change in 6MHW distance | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CardioMEMS, Left Ventricular Assist Device, Hemodynamic Management