This study is in progress, not accepting new patients

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

a study on Atrial Fibrillation Heart Conditions Cardiac Arrhythmia Ablation

Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around

Description

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.

Official Title

Assert-IQ Insertable Cardiac Monitor Post Market Study

Details

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.

Keywords

Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Cardiac Arrhythmia, Ablation, atrial fibrillation, Holter monitor, arrhythmia risk, syncope, shortness of breath, dizziness, palpitations, tachycardia, sinus pauses, Holter ECG recorder, Cardiac Arrhythmias, Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device

Eligibility

You can join if…

Open to people ages 18-100

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.

You CAN'T join if...

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.

Locations

  • University of California at San Diego (UCSD) Medical Center
    San Diego California 92103 United States
  • Shannon Clinic
    San Angelo Texas 76903 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT06172699
Study Type
Observational
Participants
Expecting 150 study participants
Last Updated