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Wrist-Worn nerve stimulator aims to tame atrial fibrillation after ablation

NCT ID NCT06748157

Disease control Sponsor: Icahn School of Medicine at Mount Sinai 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This study tests a wrist-worn device called CardiaCare RR2 that stimulates the median nerve to calm irregular heart rhythms after catheter ablation for atrial fibrillation (AF). About 34 adults who have had AF ablation will use the device daily for six months. Half will receive active stimulation, the other half a sham device. The goal is to see if this non-invasive approach can reduce early and later recurrences of AF and related symptoms.

What this could mean

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

Active substance
CardiaCare RR2 wrist-worn nerve stimulator
What this could lead to
If effective, this non-invasive device could help prevent atrial fibrillation recurrences after ablation without drugs or additional procedures.
What could go wrong
This is a small early-stage trial with only 34 participants. The device may not reduce arrhythmias, and some people may experience discomfort from the stimulation.

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

51 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Oct 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 * Men and women ages ≥18 years * Patients planned to undergo or undergoing AF ablation for paroxysmal or persistent AF and able to be randomized within 48 hours of the ablation procedure. * Ability and willingness to sign an informed consent form. * Ability and willingness to use CardiaCare RR2 device, continuous ECG monitoring, and has an available SmartPhone. Exclusion Criteria * Rheumatic heart disease * Extensive atrial disease (\* some patients may be determined to be screen failures following the ablation procedure). * Moderate to severe mitral stenosis or history of mitral valve replacement * Pacemaker or CRTD or any implanted electrical stimulating device * Unilateral or bilateral vagotomy * Peripheral neuropathy affecting the tested upper extremity. * Severe heart failure (New York Heart Association Class III or IV) within 90 days. * Recent (within 90 days) stroke or transient ischemic attack. * Recent (within 90 days) myocardial infarction. * Pregnancy or breast feeding. * Life expectancy \<1 year for any medical condition * Currently enrolled in another study that would interfere with this study * Unsuitable for participating in the study according to attending physician

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

More trials for these conditions

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