Atrial Fibrillation ParoxysmalAssert-IQNCT06172699
Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study
An observational study of Atrial Fibrillation Paroxysmal and Atrial Fibrillation, Persistent, run by Abbott Medical Devices at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Cardiac Arrhythmia
- What is being tested?
- Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device
- Type of treatment
- Medical device
- How many people
- 151 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Jan 2024to 10 Nov 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are diagnosed with symptomatic, drug-refractory paroxysmal or persistent AF, and are scheduled to receive an Assert-IQTM ICM device
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
St. Peter's Health Partners Medical Associates, PC
Albany, New York, 12205
Trinity Health-Michigan d/b/a Michigan Heart
Ann Arbor, Michigan, 48106
Trident Medical Center
Charleston, South Carolina, 29406
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Aurora Medical Group
Milwaukee, Wisconsin, 53215
Orlando Health
Orlando, Florida, 32806
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, 66211
Shannon Clinic
San Angelo, Texas, 76903
Methodist Texsan Hospital
San Antonio, Texas, 78201
University of California at San Diego (UCSD) Medical Center
San Diego, California, 92103
Heart Rhythm Associates
The Woodlands, Texas, 77380
About this study
Official title: Assert-IQ Insertable Cardiac Monitor Post Market Study
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.
Read 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 Medical.
- Conditions
- Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Cardiac Arrhythmia, Ablation
- Being tested
- Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device
- Keywords
- atrial fibrillation, Holter monitor, cardiac arrhythmia, arrhythmia risk, syncope, shortness of breath, dizziness, palpitations, tachycardia, sinus pauses, Holter ECG recorder
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Syncope, Dyspnea, Dizziness, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM deviceDevice
All enrolled subjects who meet eligibility criteria will undergo an attempted implant within 30 days of consent. After successful device implant, subjects will be followed at 1 and 12 months. Subjects will be fitted with a Holter monitor during the 1m follow-up visit and will complete a minimum of 72 hours and maximum of up to 7 days of Holter monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Subjects successfully implanted with an Abbott Assert-IQ ICM device | Holter monitoring in subjects successfully implanted with an Abbott Assert-IQ ICM device Receives: Device: Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episode-based AF detection performance metrics
Episode-based AF detection performance metrics of the Assert-IQTM ICM device compared to that of simultaneous Holter monitoring in 150 subjects who had received the Assert-IQTM ICM device as part of their standard of care.
Measured: Holter monitor worn by the subjects over a minimum 72-hour and up to 7 days period. An AF episode is defined as AF has greater or equal to 2 minutes (≥2 minutes) in duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Jan 2024
- Primary completion24 Dec 2024
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation ParoxysmalStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kwangdeok Lee, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172699
- Sponsor's protocol ID
- ABT-CIP-10468
- Acronym
- Assert-IQ
- Status last verified
- May 2026
- First submitted
- 7 Dec 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No