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

Completed

Conditions: Heart Failure

Interventions: Device: Hemodynamic management using CardioMEMS HF System

Registration Number: NCT03247829

Lead Sponsor: Abbott Medical Devices

Brief 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

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 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

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.)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment	Hemodynamic management using CardioMEMS HF System	Patients with CardioMEMS PA Sensor and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS HF System
Group B: Patients with existing HeartMate LVAD implanted with CardioMEMS PA Sensor post enrollment	Hemodynamic management using CardioMEMS HF System	Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, will receive hemodynamic management using CardioMEMS HF System

Primary Outcome Measures

Name	Time	Method
Six Minute Hall Walk (6MHW) Distance	Six Months	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (23): University of North Carolina
🇺🇸
Raleigh, North Carolina, United States
Ohio Sate University
🇺🇸
Columbus, Ohio, United States
University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
University Hospitals Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
California Pacific Medical Center - Van Ness Campus
🇺🇸
San Francisco, California, United States
University of Utah Hospital
🇺🇸
Salt Lake City, Utah, United States
San Diego Cardiac
🇺🇸
San Diego, California, United States
University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
USC University Hospital
🇺🇸
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
🇺🇸
Los Angeles, California, United States
Scripps Health
🇺🇸
La Jolla, California, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
New York-Presbyterian/Columbia University Medical Center
🇺🇸
New York, 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
The Methodist Hospital
🇺🇸
Houston, Texas, United States
The Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
The Nebraska Medical Center
🇺🇸
Omaha, Nebraska, United States
Providence Heart and Vascular Institute
🇺🇸
Portland, Oregon, United States
Aurora Medical Center
🇺🇸
Milwaukee, Wisconsin, United States
North Shore University Hospital
🇺🇸
Manhasset, New York, United States
University of Kentucky
🇺🇸
Lexington, Kentucky, United States
Palmetto Health Richland
🇺🇸
Columbia, South Carolina, United States