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

Last updated: February 18, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Circulation Disorders

Fast Heart Rate (Tachycardia)

Dysrhythmia

Treatment

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

Clinical Study ID

NCT06172699
ABT-CIP-10468
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 deviceprior to enrollment in the study.

  2. Diagnosed with symptomatic, drug-refractory paroxysmal or persistent AF prior toenrollment in the study and scheduled to undergo a first-time atrial fibrillationablation.

  3. Have a cellular phone or the ability or willing to use a mobile transmitter that iscompatible with the myMerlin™ App and able to communicate with the Assert-IQTM ICMdevice. If a subject doesn't have a cell phone or loses their cell phone, then thesite can provide a mobile transmitter to the subject. The study will not providecell phones.

  4. Are 18 years of age or older, or of legal age to give informed consent specific tostate and national law.

  5. Have the ability to provide informed consent for study participation and be willingand able to comply with the prescribed follow-up tests and schedule of evaluations.

Exclusion

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 couldconfound the results of this study, without documented pre-approval from Abbott.

  2. Subject is implanted with a cardiac implantable electronic device (CIED) with pacingcapability.

  3. Have a life expectancy of less than 1 year due to any condition.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 24, 2025

Study 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.

Connect with a study center

  • University of California at San Diego (UCSD) Medical Center

    San Diego, California 92103
    United States

    Site Not Available

  • Orlando Health

    Orlando, Florida 32806
    United States

    Site Not Available

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Trinity Health-Michigan d/b/a Michigan Heart

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • St. Peter's Health Partners Medical Associates, PC

    Albany, New York 12205
    United States

    Site Not Available

  • Trident Medical Center

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Erlanger Medical Center

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Shannon Clinic

    San Angelo, Texas 76903
    United States

    Site Not Available

  • Methodist Texsan Hospital

    San Antonio, Texas 78201
    United States

    Site Not Available

  • Heart Rhythm Associates

    The Woodlands, Texas 77380
    United States

    Site Not Available

  • Aurora Medical Group

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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