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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-24

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.

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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.

Conditions

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Atrial Fibrillation Paroxysmal Atrial Fibrillation, Persistent Cardiac Arrhythmia Ablation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects successfully implanted with an Abbott Assert-IQ ICM device

Holter monitoring in subjects successfully implanted with an Abbott Assert-IQ ICM device

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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Have an approved indication AND are scheduled to receive an Assert-IQTM ICM device prior to enrollment in the study.
2. 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.
3. 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.
4. Are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
5. 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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No