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

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03247829
• Collaborator: (none)
• Enrollment: 101
• Locations: 23
• Actual Duration (Months): 34.4
• Patients Per Site: 4.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	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 Design

• Study Type: Observational
• Actual Enrollment: 101 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Aug 17, 2017
• Actual Primary Completion Date: Mar 12, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Six Minute Hall Walk (6MHW) distance [six months]

   Change in 6MHW distance

Other Outcome Measures

1. CardioMEMS PA pressure over time [six months]

   Changes in PA pressure measurement over time

2. Days PA pressure is in the pre-specified target range [six months]

   Percentage of days PA pressure is in the pre-specified target range

3. PA pressure before 6MHW test to after 6MHW test [six months]

   Changes in PA pressure before 6MHW test to after 6MHW test

4. CardioMEMS and HeartMate Device malfunctions [six months]

   Loss of performance, such as inability to submit pressure data for CardioMEMS and/or Pump failure for LVAD

5. New York Heart Association (NYHA) classification [six months]

   NYHA classification at baseline and each scheduled follow-up visit

6. EQ-5D-5L [six months]

   Health related quality of life (EQ-5D-5L)

7. All-cause hospitalizations [six months]

   All-cause hospitalization rate

8. Worsening heart failure events [six months]

   Heart failure hospitalization rate including emergency department visits, or unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular medication management

9. 6MHW distance by PA pressure ranges [six months]

   Change in 6MHW distance by various PA pressure ranges

10. NYHA class by PA pressure ranges [six months]

    Change in NYHA class by various PA pressure ranges

11. EQ-5D-5L by PA pressure ranges [six months]

    Change in EQ-5D-5L by various PA pressure ranges

12. All cause hospitalization rate by PA pressure ranges [six months]

    All cause hospitalization rate by various PA pressure ranges

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject has CardioMEMS HF PA Sensor and a commercially-approved HeartMate LVAD (Group

1. 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

1. Signed an informed consent form and agreed to provide access to patient and device data (including CardioMEMS Merlin.net data)

2. No connectivity or transmission problems with CardioMEMS

3. On HeartMate LVAD support for at least 3 months

4. 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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Health	La Jolla	California	United States	92037
2	USC University Hospital	Los Angeles	California	United States	90033
3	Ronald Reagan UCLA Medical Center	Los Angeles	California	United States	90095
4	San Diego Cardiac	San Diego	California	United States	92123
5	California Pacific Medical Center - Van Ness Campus	San Francisco	California	United States	94109
6	University of Kentucky	Lexington	Kentucky	United States	40536
7	University of Michigan	Ann Arbor	Michigan	United States	48109
8	University of Minnesota	Minneapolis	Minnesota	United States	55455
9	The Nebraska Medical Center	Omaha	Nebraska	United States	68105
10	North Shore University Hospital	Manhasset	New York	United States	11030
11	New York-Presbyterian/Columbia University Medical Center	New York	New York	United States	10032
12	University of Rochester Medical Center	Rochester	New York	United States	14642
13	St. Francis Hospital	Roslyn	New York	United States	11576
14	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27607
15	University of North Carolina	Raleigh	North Carolina	United States	27607
16	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
17	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
18	Ohio Sate University	Columbus	Ohio	United States	43210
19	Providence Heart and Vascular Institute	Portland	Oregon	United States	97225
20	Palmetto Health Richland	Columbia	South Carolina	United States	29203
21	The Methodist Hospital	Houston	Texas	United States	77030
22	University of Utah Hospital	Salt Lake City	Utah	United States	84132
23	Aurora Medical Center	Milwaukee	Wisconsin	United States	53215

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Director: Poornima Sood, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03247829
• Other Study ID Numbers: SJM-CIP-10178
• First Posted: Aug 14, 2017
• Last Update Posted: Jan 8, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Abbott Medical Devices: CardioMEMS; Left Ventricular Assist Device; Hemodynamic Management
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Jan 8, 2021