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

Assert-IQ Insertable Cardiac Monitor Post Market Study

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation, Persistent; Cardiac Arrhythmia; Ablation; Atrial Fibrillation Paroxysmal
• Intervention / Treatment: Device: Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ 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 Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • University of California at San Diego (UCSD) Medical Center
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Kansas City Cardiac Arrhythmia Research Foundation
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Trinity Health-Michigan d/b/a Michigan Heart
  • New York
    • Albany, New York, United States, 12205
      • St. Peter's Health Partners Medical Associates, PC
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Trident Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Medical Center
  • Texas
    • San Angelo, Texas, United States, 76903
      • Shannon Clinic
    • San Antonio, Texas, United States, 78201
      • Methodist Texsan Hospital
    • The Woodlands, Texas, United States, 77380
      • Heart Rhythm Associates
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who are diagnosed with symptomatic, drug-refractory paroxysmal or persistent AF, and are scheduled to receive an Assert-IQTM ICM device

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Subjects successfully implanted with an Abbott Assert-IQ ICM device; 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; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Kwangdeok Lee, PhD, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): December 24, 2024
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: atrial fibrillation; syncope; dizziness; cardiac arrhythmia; shortness of breath; tachycardia; palpitations; Holter monitor; arrhythmia risk; sinus pauses; Holter ECG recorder
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Neurologic Manifestations; Nervous System Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Respiratory Tract Diseases; Neurobehavioral Manifestations; Respiration Disorders; Signs and Symptoms, Respiratory; Sensation Disorders; Consciousness Disorders; Unconsciousness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Atrial Fibrillation; Tachycardia; Dyspnea; Arrhythmias, Cardiac; Dizziness; Syncope; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Electrodiagnosis; Monitoring, Physiologic; Electrocardiography; Monitoring, Ambulatory; Electrocardiography, Ambulatory
• Other Study ID Numbers: ABT-CIP-10468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No