NCT03247829

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Hemodynamic management using CardioMEMS HF System	Using the CardioMEMS HF System, clinicians will treat to target PA pressure ranges

Timeline

• Start date: 2017-08-24
• Primary completion: 2020-03-06
• Completion: 2020-06-30
• First posted: 2017-08-14
• Last updated: 2024-04-26
• Results posted: 2024-04-26

Locations

23 sites across 1 country: United States