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

Completed

Conditions studied: Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Cardiac Arrhythmia, Ablation

In brief

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.

Key facts

Study ID

NCT06172699

Run by

Abbott Medical Devices

People needed

151

Starts

2024-01-01

Expected to finish

2025-11-10

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet ALL study inclusion criteria to participate in the study.
• Have an approved indication AND are scheduled to receive an Assert-IQTM ICM device prior to enrollment in the study.
• 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.
• 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.
• Are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
• 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 may not qualify if…

• If ANY study exclusion criteria are met, the patient is excluded from the study and cannot be enrolled (recruitment failure).
• Subject is currently participating in another clinical investigation that could confound the results of this study, without documented pre-approval from Abbott.
• Subject is implanted with a cardiac implantable electronic device (CIED) with pacing capability.
• Have a life expectancy of less than 1 year due to any condition.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.