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

Heart Failure Clinical Trial

— INTELLECT 2-HF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247829
• Other study ID #: SJM-CIP-10178
• Status: Completed
• Start date: August 24, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 30, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Hemodynamic management using CardioMEMS HF System
Using the CardioMEMS HF System, clinicians will treat to target PA pressure ranges

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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