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ACTIVE NOT RECRUITING
NCT06172699

Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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

DEVICE

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