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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assert-IQ Insertable Cardiac Monitor Post Market Study

Conditions
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Atrial Fibrillation, Persistent, Cardiac Arrhythmia, Atrial Fibrillation Paroxysmal, Ablation

Intervention / Treatment
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* Device: Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects successfully implanted with an Abbott Assert-IQ ICM device<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, Holter monitor, cardiac arrhythmia, arrhythmia risk, syncope, shortness of breath, dizziness, palpitations, tachycardia, sinus pauses, Holter ECG recorder