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New heart device aims to zap away irregular rhythm

NCT ID NCT05462145

Disease control Sponsor: Kardium 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new device called the Globe Pulsed Field System to treat people with atrial fibrillation (AF), a common heart rhythm problem. The device uses electrical pulses to destroy small areas of heart tissue causing the irregular rhythm. About 549 participants will be followed for 12 months to see if the procedure is safe and effective at preventing AF episodes.

What this could mean

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

Active substance
Globe Pulsed Field System (a device that uses electrical pulses to ablate heart tissue)
What this could lead to
If successful, this could provide a new, safer way to control atrial fibrillation and reduce symptoms without long-term medication.
What could go wrong
This is an early-stage study without a control group, so results may not confirm effectiveness. Risks include procedure-related complications like bleeding or heart rhythm issues.

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 549 people

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

Started

Mar 2023

Expected to finish

Sep 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 to 80 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.

Key inclusion criteria: * A diagnosis of recurrent symptomatic paroxysmal or persistent AF * Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III Key exclusion criteria: * Long-standing persistent AF (sustained \>12 months) * Atrial fibrillation secondary to a reversible cause or of non-cardiac origin * History of thromboembolic events within the past six months * Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months * Any cardiac surgery within the previous six months * Prior left atrial ablation or surgical procedure * Presence of an implanted cardiac device * Body mass index (BMI) \>40 kg/m\^2 * Left ventricular ejection fraction (LVEF) \<35% * Anterior-posterior left atrial (LA) diameter \>55mm

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Paroxysmal atrial fibrillation Persistent atrial fibrillation

Contacts and locations

Locations

  • Beaumont Hospital

    Royal Oak, Michigan, 48073, United States

  • Charité Campus Virchow Clinic

    Berlin, Germany

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901, United States

  • Grandview Medical Center

    Birmingham, Alabama, 35243, United States

  • Heart and Diabetes Center NRW

    Bad Oeynhausen, Germany

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Mercy Hospital

    Miami, Florida, 33133, United States

  • Motol and Homolka University Hospital

    Prague, Czechia

  • Mt. Sinai Hospital, Guggenheim Pavilion

    New York, New York, 10029, United States

  • St. Bernards Medical Center

    Jonesboro, Arkansas, 72401, United States

  • St. Vincent's Medical Center

    Jacksonville, Florida, 32204, United States

  • St.Paul's Hospital

    Vancouver, British Columbia, V6E 1M7, Canada

  • Sutter Health - California Pacific Medical Center

    San Francisco, California, 94109, United States

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • Westpfalz-Klinikum GmbH Kaiserslautern

    Kaiserslautern, 67655, Germany

More trials for these conditions

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