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New heart device aims to zap away irregular heartbeat

NCT ID NCT05164107

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device that uses short bursts of energy (pulsed field ablation) to treat atrial fibrillation, a common heart rhythm problem. The device maps the heart and then delivers energy to specific areas to correct the rhythm. Researchers will enroll 175 people to see if the procedure is safe and works well.

What this could mean

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

Active substance
Globe Mapping and Pulsed Field Ablation System (Globe PF System)
What this could lead to
If successful, this could provide a safer, more precise way to treat atrial fibrillation, potentially reducing complications and improving outcomes.
What could go wrong
This is an early pilot study with no control group, so results are preliminary. The procedure carries risks like any heart ablation, including bleeding, heart damage, or irregular heartbeats.

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 175 people

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

Started

Dec 2021

Expected to finish

May 2027

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 75 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: 1. Subjects planned for an AF catheter ablation procedure, with a documented history of AF. 1. Diagnosis must be confirmed within 12 months before enrollment. 2. (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation 2. Subjects between 18 and 75 years of age, inclusive Key Exclusion Criteria: 1. Patients who have contraindications to open heart surgery 2. Patients from an Intensive Care Unit 3. Patients with active systemic infection (sepsis) 4. Patients who have had previous ablation in the left or right atrium 5. Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery 6. Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder) 7. Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation 8. Patients with New York Heart Association Class III or IV heart failure 9. History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA) 10. Bleeding disorder history 11. Patients with a known sensitivity to anesthesia or neuromuscular block agent 12. Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease 13. Myocardial infarction within the last three months 14. Atrioventricular (AV) block II° or III° 15. Left ventricular ejection fraction (LVEF) of less than 35% 16. Unstable angina

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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

    1 site. 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

  • Motol and Homolka University Hospital

    RECRUITING

    Prague, 150 00, Czechia

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