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Assert-IQTM Insertable Cardiac Monitor Post Market Study

Assert-IQTM Insertable Cardiac Monitor Post Market Study

  • Clinical Trial Information

    Trial Contact: Marquart, Vashnie; Ngo, George M.; Rodriguez, Jessica Marie

  • IRB No: W23.208.10

    Protocol Abbrev: Assert-IQ

    Principal Investigator: Luis Ernesto Garcia Suero, MD

    Phase: Device: Non-significant Risk

    Age Group: Adult

    Secondary Protocol No: ABT-CIP-10468 Ver. B

    Treatment: Implantation of Assert-IQTM ICM device

    Therapies Involved: Procedural

    ClinicalTrials.gov ID: NCT06172699

  • Objective

    To collect data to be able to evaluate the performance of the enhanced atrial fibrillation detection algorithm of the Assert-IQTM ICM device in subjects who are scheduled to receive an Assert-IQTM ICM device prior to enrollment in the study.

  • Key Eligibility

    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.