Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
NCT ID: NCT03247829
Last Updated: 2024-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
101 participants
OBSERVATIONAL
2017-08-24
2020-06-30
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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
Hemodynamic management using CardioMEMS HF System
Using the CardioMEMS HF System, clinicians will treat to target PA pressure ranges
Interventions
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Hemodynamic management using CardioMEMS HF System
Using the CardioMEMS HF System, clinicians will treat to target PA pressure ranges
Eligibility Criteria
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Inclusion Criteria
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
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.)
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Kartik Sundareswaran
Role: STUDY_DIRECTOR
Abbott
Locations
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Scripps Health
La Jolla, California, United States
USC University Hospital
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
San Diego Cardiac
San Diego, California, United States
California Pacific Medical Center - Van Ness Campus
San Francisco, California, United States
University of Kentucky
Lexington, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
The Nebraska Medical Center
Omaha, Nebraska, United States
North Shore University Hospital
Manhasset, New York, United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
St. Francis Hospital
Roslyn, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of North Carolina
Raleigh, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio Sate University
Columbus, Ohio, United States
Providence Heart and Vascular Institute
Portland, Oregon, United States
Palmetto Health Richland
Columbia, South Carolina, United States
The Methodist Hospital
Houston, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Aurora Medical Center
Milwaukee, Wisconsin, United States
Countries
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References
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Thohan V, Abraham J, Burdorf A, Sulemanjee N, Jaski B, Guglin M, Pagani FD, Vidula H, Majure DT, Napier R, Heywood TJ, Cogswell R, Dirckx N, Farrar DJ, Drakos SG; INTELLECT 2-HF Investigators. Use of a Pulmonary Artery Pressure Sensor to Manage Patients With Left Ventricular Assist Devices. Circ Heart Fail. 2023 Jun;16(6):e009960. doi: 10.1161/CIRCHEARTFAILURE.122.009960. Epub 2023 Apr 20.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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SJM-CIP-10178
Identifier Type: -
Identifier Source: org_study_id
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