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

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.

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Key information

Conditions

Atrial Fibrillation Paroxysmal Ablation Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation, Persistent Cardiac Arrhythmia Cardiac Conduction System Disease Cardiovascular Diseases Consciousness Disorders Dizziness Dyspnea Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sensation Disorders Signs and Symptoms Signs and Symptoms, Respiratory Syncope Tachycardia Unconsciousness

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California at San Diego (UCSD) Medical Center, San Diego, California, United States

About this study

The study's intent is to generate long-term real-world data on the safety, performance, and clinical benefits of the Assert-IQTM ICM device system. This clinical investigation is sponsored by Abbott Medical.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must meet ALL study inclusion criteria to participate in the study.

Have an approved indication AND are scheduled to receive an Assert-IQTM ICM device prior to enrollment in the study.
Diagnosed with symptomatic, drug-refractory paroxysmal or persistent AF prior to enrollment in the study and scheduled to undergo a first-time atrial fibrillation ablation.
Have a cellular phone or the ability or willing to use a mobile transmitter that is compatible with the myMerlin™ App and able to communicate with the Assert-IQTM ICM device. If a subject doesn't have a cell phone or loses their cell phone, then the site can provide a mobile transmitter to the subject. The study will not provide cell phones.
Are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Exclusion criteria

If ANY study exclusion criteria are met, the patient is excluded from the study and cannot be enrolled (recruitment failure).

Subject is currently participating in another clinical investigation that could confound the results of this study, without documented pre-approval from Abbott.
Subject is implanted with a cardiac implantable electronic device (CIED) with pacing capability.
Have a life expectancy of less than 1 year due to any condition.

Treatment and study plan

Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device

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.

Primary outcomes

Episode-based AF detection performance metrics

Time frame: Holter monitor worn by the subjects over a minimum 72-hour and up to 7 days period. An AF episode is defined as AF has greater or equal to 2 minutes (≥2 minutes) in duration.

Episode-based AF detection performance metrics of the Assert-IQTM ICM device compared to that of simultaneous Holter monitoring in 150 subjects who had received the Assert-IQTM ICM device as part of their standard of care.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Assert-IQ Insertable Cardiac Monitor Post Market Study

Acronym: Assert-IQ

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Dec 15, 2023
Registry last updated: May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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