NCT06172699Completed
Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study
Assert-IQ Insertable Cardiac Monitor Post Market Study
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 151 (actual)
- First submitted
- 7 Dec 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 24 Dec 2024
- Lead sponsor
- Abbott Medical Devices
- Diseases
- Atrial fibrillation
- NCT number
- NCT06172699
What you commit to
- Study type: Observational
- Participants enrolled: 151
- From 1 Jan 2024 to the primary completion date, 24 Dec 2024
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- If ANY study exclusion criteria are met, the patient is excluded from the study and cannot be enrolled (recruitment failure).
- 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.
Other
- Subject is currently participating in another clinical investigation that could confound the results of this study, without documented pre-approval from Abbott.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Peter's Health Partners Medical Associates, PC Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Trinity Health-Michigan d/b/a Michigan Heart Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Trident Medical Center Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Erlanger Medical Center Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Aurora Medical Group Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Orlando Health Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Kansas City Cardiac Arrhythmia Research Foundation Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Shannon Clinic Coordinator of this site? Confirm its status | San Angelo | United States | Unknown status |
| Methodist Texsan Hospital Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| University of California at San Diego (UCSD) Medical Center Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Heart Rhythm Associates Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.