Status:
ACTIVE_NOT_RECRUITING
Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Atrial Fibrillation Paroxysmal
Atrial Fibrillation, Persistent
Eligibility:
All Genders
18-100 years
Brief 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 ...
Detailed 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 M...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 24 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06172699
Start Date
January 1 2024
End Date
December 24 2025
Last Update
February 20 2025
Active Locations (11)
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1
University of California at San Diego (UCSD) Medical Center
San Diego, California, United States, 92103
2
Orlando Health
Orlando, Florida, United States, 32806
3
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, United States, 66211
4
Trinity Health-Michigan d/b/a Michigan Heart
Ann Arbor, Michigan, United States, 48106