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New device aims to protect the breathing nerve during heart ablation

NCT ID NCT07820631

Diagnosis Sponsor: Circle Safe, Inc. 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing the Circle Safe System, a device that stimulates the phrenic nerve and records the diaphragm's electrical response during pulmonary vein ablation for atrial fibrillation. The study enrolls up to 50 adults scheduled for this procedure. All participants receive the device during treatment of the right pulmonary veins, and researchers track whether it can reliably capture and display the diaphragm's signal and whether any device-related safety problems occur through hospital discharge.

What this could mean

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

Active substance
Circle Safe System, a catheter-based device that stimulates the phrenic nerve and records the diaphragm's electrical response during ablation
What this could lead to
If it works, this device could give heart rhythm doctors a real-time way to watch the phrenic nerve during ablation and avoid injuring the diaphragm.
What could go wrong
This is a first-in-human study with 50 participants and no comparison group, so safety and performance data are early and may not hold up in larger studies. Device placement or nerve stimulation could cause complications such as blood vessel damage or stroke.

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 50 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

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.

Ages

19 to 84 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: 1. Male or females \>18 and ≤ 85 years of age 2. Subject willing to sign informed consent 3. Subject is a candidate for pulmonary vein ablation for the treatment of atrial fibrillation ablation procedures therapy Exclusion Criteria: 1. Subjects with pacemaker or defibrillator leads placed through the vena cava 2. Subjects with implantable vena cava filter 3. Subjects with a contraindication to contrast dye 4. Pregnant subjects 5. Subjects with inadequate venous access due to prior vein thrombosis or indwelling chronic ports or catheters 6. Subjects participating in another clinical trial that has not reached the follow-up time point to primary endpoint assessment 7. Subjects with known neuromuscular disease or other medical history (i.e trauma, surgery) that could have impacted diaphragmatic function

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • CHU Timone - APHM

    Marseille, 13005, France

  • Clinique Pasteur

    Toulouse, 31300, France

  • Hôpital Cardiologique du Haut Lévèque

    Pessac, 33604, France

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