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

Active, not recruiting

• Conditions: Ablation; Cardiac Arrhythmia; Atrial Fibrillation Paroxysmal; Atrial Fibrillation, Persistent
• Interventions: Device: Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device

• Registration Number: NCT06172699
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Study Start: 2024-01-01
• Primary Completion: 2024-12-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Study Completion: 2025-12-24

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Episode-based AF detection performance metrics	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.	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.

Trial Locations

Locations (11)

University of California at San Diego (UCSD) Medical Center; 🇺🇸 San Diego, California, United States

Orlando Health; 🇺🇸 Orlando, Florida, United States

Kansas City Cardiac Arrhythmia Research Foundation; 🇺🇸 Overland Park, Kansas, United States

Trinity Health-Michigan d/b/a Michigan Heart; 🇺🇸 Ann Arbor, Michigan, United States

St. Peter's Health Partners Medical Associates, PC; 🇺🇸 Albany, New York, United States

Trident Medical Center; 🇺🇸 Charleston, South Carolina, United States

Erlanger Medical Center; 🇺🇸 Chattanooga, Tennessee, United States

Shannon Clinic; 🇺🇸 San Angelo, Texas, United States

Methodist Texsan Hospital; 🇺🇸 San Antonio, Texas, United States

Heart Rhythm Associates; 🇺🇸 The Woodlands, Texas, United States

Aurora Medical Group; 🇺🇸 Milwaukee, Wisconsin, United States