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Heart monitor after ablation may cut AF time

NCT ID NCT04922281

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using an implantable heart monitor (or a wearable patch) to detect atrial fibrillation early after catheter ablation can reduce the total time spent in AF. About 120 people with paroxysmal or persistent AF will be monitored for 15 months. The goal is to see if early treatment guided by the monitor lowers AF burden and healthcare use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Insertable cardiac monitor (Confirm Rx) or external LT-ECG patch (CAM)
What this could lead to
If successful, this could show that early detection and treatment of atrial fibrillation after ablation reduces the total time spent in AF, improving heart health.
What could go wrong
This is a small, early-phase study with only 120 participants, so results may not apply to everyone. The monitoring devices may cause discomfort or skin irritation.

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 120 people

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

Started

Feb 2022

Expected to finish

Dec 2026

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 * History of paroxysmal atrial fibrillation (per 2019 HRS guidelines definition: an episode of AF that terminates spontaneously or with intervention in less than seven days), according to current guideline indications for paroxysmal AF CA (Class I/II); or patients with history of persistent atrial fibrillation (per 2019 HRS guidelines definition: sustained AF episode lasting more than 7 days, but less than 3 years), according to current guideline indications for persistent AF CA (Class I/IIIa) any time in the past. * 18 years of age or older at time of consent * CA to be performed for AF as standard of care within 2 calendar months after consent and prior to randomization date * One of the following: * Abbott ICM device indicated for monitoring symptoms after CA as standard of care and inserted within 2 calendar months after consent and prior to randomization date * Patients with an existing CIED (ICD/CRTD/PPM/ICM) are allowed if there is an atrial lead to track AF. * Patient without an existing CIED preferring to use a noninvasive LT-ECG monitor. Exclusion criteria * Inability or unwilling to undergo CA (e.g., presence of intra-cardiac thrombus, contraindication to anticoagulation or other contraindication to CA) * Inability to tolerate any AAD therapy * Permanent atrial fibrillation lasting more than 3 years prior to date of consent * NYHA class IV congestive heart failure * Life expectancy \<1 year after consent date for any medical condition * Pregnancy or nursing * Unwillingness to comply with all post-procedural follow-up requirements and to sign informed consent * Participation in other interventional research studies (observational registries are allowed).

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation cardiac rhythm disease cardiovascular disorder heart disorder paroxysmal atrial fibrillation Pathologic Processes persistent atrial fibrillation

As listed by the trial registrant

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

Arrhythmias, cardiac Atrial fibrillation Cardiovascular diseases Heart diseases Pathologic processes

Contacts and locations

Locations

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

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