Active — Not RecruitingNot Applicable

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

United States150 participantsStarted 2024-01-01

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. 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

✕. 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.

What they're measuring

Episode-based AF detection performance metrics

Timeframe: 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.

Trial details

NCT IDNCT06172699

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-24

View on ClinicalTrials.gov More Atrial Fibrillation Paroxysmal trials