Clinical trial NCT03247829: Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
Official title: Investigation to Optimize Hemodynamic Management of HeartMate II™ Left Ventricular Assist Device Patients Using the CardioMEMS™ Pulmonary Artery Pressure Sensor in Advanced Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: CardioMEMS
Left Ventricular Assist Device
Hemodynamic Management
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-08-14
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart Failure patients will be recruited from the clinicians practice based on the presence of both devices under study

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

Eligibility criteria: 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.)

Primary outcomes:
measure: Six Minute Hall Walk (6MHW) Distance
timeFrame: Six Months
Secondary outcomes:
Other outcomes:
measure: Change in PA Diastolic Pressure From Baseline to 6 Months
timeFrame: six months
measure: Days PA Diastolic Pressure is in the Pre-specified Target Range
timeFrame: six months
measure: PA Diastolic Pressure Before 6MHW Test to After 6MHW Test
timeFrame: 6 months
measure: Number of Subjects With Either CardioMEMS or HeartMate Device Malfunctions
timeFrame: six months
measure: New York Heart Association (NYHA) Classification
timeFrame: six months
measure: EQ-5D-5L VAS
timeFrame: six months
measure: Number and Percent of Participants With All-cause Hospitalizations.
timeFrame: six months
measure: Number and Percent of Participants With Worsening Heart Failure Events
timeFrame: six months
Locations:
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: San Diego
country: United States
facility: San Diego Cardiac
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Van Ness Campus
state: California
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Omaha
country: United States
facility: The Nebraska Medical Center
state: Nebraska
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: New York-Presbyterian/Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Raleigh
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio Sate University
state: Ohio
city: Portland
country: United States
facility: Providence Heart and Vascular Institute
state: Oregon
city: Columbia
country: United States
facility: Palmetto Health Richland
state: South Carolina
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Milwaukee
country: United States
facility: Aurora Medical Center
state: Wisconsin
Study officials:
affiliation: Abbott
name: Kartik Sundareswaran
role: STUDY_DIRECTOR
References: