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

Abbott

Status: Active, not recruiting

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

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

Study type: Observational

Funder types: Industry

Identifiers

NCT06172699

ABT-CIP-10468

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

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

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.

Trial design

150 participants in 1 patient group

Subjects successfully implanted with an Abbott Assert-IQ ICM device

Description:

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

Treatment:

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