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New radiofrequency wire aims to make heart procedures safer

NCT ID NCT07361445

Disease control 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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests a new device that uses a special wire with radiofrequency energy to safely cross the wall between the heart's upper chambers. This step is needed for procedures that treat heart rhythm problems or close the left atrial appendage. The study will enroll 60 adults and follow them only until they leave the hospital.

What this could mean

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

Active substance
Agilis RF Transseptal System (radiofrequency wire device)
What this could lead to
If successful, this device could make heart procedures safer and more reliable by improving how doctors access the left side of the heart.
What could go wrong
This is a very early, first-in-human study with only 60 people and no long-term follow-up. The device may not work as expected or could cause complications like heart injury or bleeding.

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 60 people

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

Started

Feb 2026

Expected to finish

Aug 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

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: * Is able and willing to provide written informed consent prior to any clinical investigation-related procedure * Plans to undergo an ablation procedure in LA, LV or concomitant procedure with ablation and LAAO device implantation requiring transseptal puncture * Is at least 18 years of age * Able and willing to comply with all study requirements Exclusion Criteria: * Currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from the study Sponsor * Pregnant or nursing * Known presence of intracardiac thrombus * Known existing circumferential pericardial effusion (\>2 mm) * Previous interatrial septal patch or prosthetic atrial septal defect closure device * Any previous thromboembolic event with in the last 6 months * Known or suspected left atrial myxoma * Known or suspected myocardial infarction within the last two weeks * Unstable angina * Recent (within the last 3 months) cerebral vascular accident (CVA) * Patients with an active infection * Patients who do not tolerate anticoagulation therapy * Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results

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Conditions

The condition(s) this trial relates to.

cardiac rhythm disease 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.

Cardiac arrythmias Left atrial appendage closure

How to take part

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

  1. The places running it

    3 sites. 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

  • Arrhythmia Research Group (St. Bernards)

    RECRUITING

    Jonesboro, Arkansas, 72401, United States

  • California Pacific Medical Center -Van Ness Campus

    RECRUITING

    San Francisco, California, 94109, United States

  • Research Medical Center

    RECRUITING

    Kansas City, Missouri, 64132, United States

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