Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™ (INTELLECT 2-HF)

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 HF System

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

• 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 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.)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment; Patients with CardioMEMS PA Sensor and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS HF System	Device: Hemodynamic management using CardioMEMS HF System; Using the CardioMEMS HF System, clinicians will treat to target PA pressure ranges
Group B: Patients with existing HeartMate LVAD implanted with CardioMEMS PA Sensor post enrollment; 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	Device: Hemodynamic management using CardioMEMS HF System; 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 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.	Six Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PA Diastolic Pressure From Baseline to 6 Months	Changes in PA diastolic pressure measurement over time from baseline to 6 months follow-up.	six months
Days PA Diastolic Pressure is in the Pre-specified Target Range	Average number of days PA diastolic pressure was in the pre-specified target range of 8-15 mmHg. For this measure, both arms were combined to assess the mean number of days, all study subjects spent in the target PA diastolic range. This was pre-defined as a whole population analysis.	six months
PA Diastolic Pressure Before 6MHW Test to After 6MHW Test	Pulmonary Artery Diastolic Pressure collected using the CardioMEMS-HF system before and after the 6MHW test.	6 months
Number of Subjects With Either CardioMEMS or HeartMate Device Malfunctions	Loss of performance, such as inability to submit pressure data for CardioMEMS and/or Pump failure for LVAD. This measure is independent of study arm as both patients had both devices at enrollment. This was pre-defined as a whole population analysis.	six months
New York Heart Association (NYHA) Classification	Change in NYHA classification from baseline assessed at 6 months. New York Heart Association (NYHA) Functional Classification stratifies patients' heart failure (HF) by the severity of their symptoms. I - No limitation of physical activity. II - Slight limitation of physical activity. Comfortable at rest. III - Marked limitation of physical activity. Comfortable at rest. IV - Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.	six months
EQ-5D-5L VAS	Health related quality of life (EQ-5D-5L). The EQ-5D-5L self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life. For this measure, both arms were combined to assess the mean of and changes to the EQ-5D-5L VAS for all study subjects, as all subjects were treated the same and had the same devices once enrolled. This was pre-defined as a whole population analysis.	six months
Number and Percent of Participants With All-cause Hospitalizations.	Number and percent of participants who were hospitalized for any cause during follow-up.	six months
Number and Percent of Participants With Worsening Heart Failure Events	Worsening HF events incudes emergency department visits, or unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular medication management.	six months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Kartik Sundareswaran, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2017
• Primary Completion (Actual): March 6, 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): April 26, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2023
• 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