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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05428384
Other study ID # ABT-CIP-10448
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 31, 2022
Est. completion date January 30, 2024

Study information

Verified date June 2024
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigation will enroll subjects who have been previously implanted with the CardioMEMS™ Pulmonary Artery Sensor. This clinical investigation is twofold; in the first phase (development phase) data collected will be used to complete development of an algorithm that can estimate cardiac output from CardioMEMS™ Heart Failure System readings. The second phase (validation phase) of this clinical investigation is intended to compare the Cardiac Output estimate from CardioMEMS HF System to Cardiac Output estimates from Cardiac Magnetic Resonance Imaging (reference standard).


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
MRI/ CardioMEMS comparison
Each subject will have CardioMEMS readings paired with MRI scans

Locations

Country Name City State
United States Piedmont Augusta Hospital Augusta Georgia
United States Austin Heart Austin Texas
United States Kansas University Medical Center Kansas City Kansas
United States University of Minnesota Medical Center Fairview Minneapolis Minnesota
United States St. Francis Hospital New York New York
United States Sentara Norfolk General Hospital Norfolk Virginia
United States Sanford USD Medical Center Sioux Falls South Dakota
United States Ascension Providence Hospital Southfield Michigan

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac output estimation The primary outcome of this clinical investigation is to estimate Cardiac Output from CardioMEMS HF System data. The estimated Cardiac Output will be evaluated for agreement between the CardioMEMS HF System-derived Cardiac Output and the Cardiac Output values from cardiac Magnetic Resonance Imaging in patients with the CardioMEMS HF System 18 months
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