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Tiny implant could spot hidden heart risk in millions

NCT ID NCT04818645

Knowledge-focused Sponsor: University of Rochester 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a small device placed under the skin can detect hidden atrial fibrillation (an irregular heartbeat) in people with heart failure who are at high risk for stroke. About 477 participants either received the implant or standard care. The goal is to see if the monitor finds irregular rhythms earlier and helps doctors start treatments to prevent strokes and hospitalizations.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 477 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Male and female patients more than 18 years of age (no upper age limit) * HF exacerbation requiring initiation or augmentation of decongestive therapy in a hospital setting (hospitalization or emergency department visit) during the past 24 calendar months prior to consent date OR current treatment with loop-diuretics (furosemide, bumetanide, or torsemide). * LVEF \> 35% on a cardiac imaging study (echocardiogram, nuclear imaging, cardiac magnetic resonance imaging) performed during the past 24 calendar months prior to consent date * One or more FDA-approved indications for an Abbott ICM (unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias). * Willing to undergo an Abbott ICM implant and agree to remote ICM monitoring. Exclusion Criteria: * Existing implantable cardioverter defibrillator (ICD), biventricular ICD, implantable cardiac monitor or pacemaker. * Known or documented history AF or atrial flutter any time in past. * Has had a heart transplant * Participation in other clinical trials (observational registries are allowed with approval from the Coordination Center) * Unable or unwilling to cooperate with the protocol * Unable or unwilling to sign the consent for participation

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Conditions

The condition(s) this trial relates to.

atrial fibrillation heart failure stroke disorder

As listed by the trial registrant

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

Atrial fibrillation Heart failure

Contacts and locations

Locations

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.