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New heart monitor algorithm put to the test

NCT ID NCT06172699

Knowledge-focused Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well a new heart monitor (Assert-IQ) detects atrial fibrillation (an irregular heartbeat) in people who have had a heart ablation procedure. 151 participants wore the monitor as part of their normal care. Researchers compared the monitor's readings to a standard Holter monitor to see how accurate the new device's detection algorithm is.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

151 people

The number who actually took part.

Started

Jan 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects who are diagnosed with symptomatic, drug-refractory paroxysmal or persistent AF, and are scheduled to receive an Assert-IQTM ICM device

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. Exclusion Criteria: 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.

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation Dizziness Dyspnea paroxysmal atrial fibrillation persistent atrial fibrillation Syncope Tachycardia ventricular arrhythmias due to cardiac ryanodine receptor calcium release deficiency syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ablation Atrial fibrillation (paroxysmal) Atrial fibrillation, persistent Cardiac arrhythmia

Contacts and locations

Locations

  • Aurora Medical Group

    Milwaukee, Wisconsin, 53215, United States

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403, United States

  • Heart Rhythm Associates

    The Woodlands, Texas, 77380, United States

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas, 66211, United States

  • Methodist Texsan Hospital

    San Antonio, Texas, 78201, United States

  • Orlando Health

    Orlando, Florida, 32806, United States

  • Shannon Clinic

    San Angelo, Texas, 76903, United States

  • St. Peter's Health Partners Medical Associates, PC

    Albany, New York, 12205, United States

  • Trident Medical Center

    Charleston, South Carolina, 29406, United States

  • Trinity Health-Michigan d/b/a Michigan Heart

    Ann Arbor, Michigan, 48106, United States

  • University of California at San Diego (UCSD) Medical Center

    San Diego, California, 92103, United States

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