Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™ (Intellect2)

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Hemodynamic management using CardioMEMS

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

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Health
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 90033
      • USC University Hospital
    • San Diego, California, United States, 92123
      • San Diego Cardiac
    • San Francisco, California, United States, 94109
      • California Pacific Medical Center - Van Ness Campus
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • The Nebraska Medical Center
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10032
      • New York-Presbyterian/Columbia University Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27607
      • University of North Carolina at Chapel Hill
    • Raleigh, North Carolina, United States, 27607
      • University of North Carolina
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio Sate University
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Heart and Vascular Institute
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Palmetto Health Richland
  • Texas
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 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.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with CardioMEMS and LVAD; Patients with CardioMEMS and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS	Device: Hemodynamic management using CardioMEMS; Using the CardioMEMS HF system, clinicians will treat to target PA pressure ranges

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CardioMEMS PA pressure over time	Changes in PA pressure measurement over time	six months
Days PA pressure is in the pre-specified target range	Percentage of days PA pressure is in the pre-specified target range	six months
PA pressure before 6MHW test to after 6MHW test	Changes in PA pressure before 6MHW test to after 6MHW test	six months
CardioMEMS and HeartMate Device malfunctions	Loss of performance, such as inability to submit pressure data for CardioMEMS and/or Pump failure for LVAD	six months
New York Heart Association (NYHA) classification	NYHA classification at baseline and each scheduled follow-up visit	six months
EQ-5D-5L	Health related quality of life (EQ-5D-5L)	six months
All-cause hospitalizations	All-cause hospitalization rate	six months
Worsening heart failure events	Heart failure hospitalization rate including emergency department visits, or unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular medication management	six months
6MHW distance by PA pressure ranges	Change in 6MHW distance by various PA pressure ranges	six months
NYHA class by PA pressure ranges	Change in NYHA class by various PA pressure ranges	six months
EQ-5D-5L by PA pressure ranges	Change in EQ-5D-5L by various PA pressure ranges	six months
All cause hospitalization rate by PA pressure ranges	All cause hospitalization rate by various PA pressure ranges	six months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Poornima Sood, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2017
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Left Ventricular Assist Device; CardioMEMS; Hemodynamic Management
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SJM-CIP-10178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No