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Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study
Sponsor: Abbott Medical Devices
Summary
This is a prospective, non-randomized, multi-center, real-world post-market study to collect and evaluate data regarding the performance of the enhanced atrial fibrillation detection algorithm of the Assert-IQTM Implantable Cardiac Monitor (ICM) device.
Official title: Assert-IQ Insertable Cardiac Monitor Post Market Study
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2024-01-01
Completion Date
2025-12-24
Last Updated
2025-02-20
Healthy Volunteers
No
Interventions
Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device
All enrolled subjects who meet eligibility criteria will undergo an attempted implant within 30 days of consent. After successful device implant, subjects will be followed at 1 and 12 months. Subjects will be fitted with a Holter monitor during the 1m follow-up visit and will complete a minimum of 72 hours and maximum of up to 7 days of Holter monitoring.
Locations (11)
University of California at San Diego (UCSD) Medical Center
San Diego, California, United States
Orlando Health
Orlando, Florida, United States
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, United States
Trinity Health-Michigan d/b/a Michigan Heart
Ann Arbor, Michigan, United States
St. Peter's Health Partners Medical Associates, PC
Albany, New York, United States
Trident Medical Center
Charleston, South Carolina, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
Shannon Clinic
San Angelo, Texas, United States
Methodist Texsan Hospital
San Antonio, Texas, United States
Heart Rhythm Associates
The Woodlands, Texas, United States
Aurora Medical Group
Milwaukee, Wisconsin, United States