An observational study in Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent and Cardiac Arrhythmia, sponsored by Abbott Medical Devices. Completed at 11 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Abbott Medical Devices (part of Abbott) · Observational
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.
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 151 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects who are diagnosed with symptomatic, drug-refractory paroxysmal or persistent AF, and are scheduled to receive an Assert-IQTM ICM device
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must meet ALL study inclusion criteria to participate in the study.
Exclusion Criteria:
If ANY study exclusion criteria are met, the patient is excluded from the study and cannot be enrolled (recruitment failure).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Holter monitoring in subjects successfully implanted with an Abbott Assert-IQ ICM device
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.
Episode-based AF detection performance metrics
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.
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.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Dec 2024, 11 months.
Of 148 industry-sponsored observational studies under Atrial Fibrillation, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 42. This study's 11 months is below that.
Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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