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Zapping heart rhythm problems: new device uses electrical pulses to treat AFib

NCT ID NCT05572047

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests a new device that uses special electrical pulses (coherent sine-burst electroporation) to treat atrial fibrillation, a common heart rhythm problem. The device aims to isolate the pulmonary veins, which are often the source of the abnormal signals. The study will enroll 25 people with paroxysmal or persistent AFib who have not responded to medication, to see if the procedure is safe and effective.

What this could mean

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

Active substance
Coherent sine-burst electroporation (CSE) ablation system (device)
What this could lead to
If successful, this could offer a new, potentially safer way to treat atrial fibrillation by using targeted electrical pulses instead of heat or cold to destroy abnormal heart tissue.
What could go wrong
This is a very early pilot study with only 25 people, so results may not apply to everyone. The procedure carries risks like any heart ablation, including serious side effects. It is not yet proven to be better than existing treatments.

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 25 people

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

Started

Oct 2022

Expected to finish

Jun 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.

Inclusion Criteria: * Scheduled for ablation of paroxysmal or persistent AF * Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the duration of the study * Willing and able to give informed consent * Failed at least one antiarrhythmic drug (AAD) (Class I to IV) as evidenced by recurrent symptomatic AF or intolerable or contraindicated to the AAD Exclusion Criteria: * Contraindication to AF ablation, TEE or anticoagulation * Duration of continuous AF lasting longer than 12 months * History of previous LA ablation or surgical treatment of AF/AT/AFL * AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause * Structural heart disease described as: * LVEF \<30% based on TTE within 6 months of procedure * Left atrial size \> 50mm based on TTE within 6 months of procedure (parasternal view) * An implanted pacemaker or ICD * Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG) * Previous cardiac valvular surgical or percutaneous procedure or prosthetic valve * Interatrial baffle, closure device, patch, ASD or PFO * Presence of a left atrial appendage occlusion device * CABG or PTCA procedure within the last 6 months * Unstable angina or ongoing myocardial ischemia * Myocardial infarction within the previous 6 months * Hypertrophic cardiomyopathy defined as left ventricular septal wall thickness \> 1.5cm * History of blood clotting or bleeding disease * Prior history within the previous 6 months of documented cerebral infarction, TIA or system embolism * Pregnant or lactating (current or anticipated within study follow-up) * Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcomes measurement for this study * Any other condition, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Israeli-Georgian Medical Research Clinic Helthycore Ltd

    Tbilisi, 0112, Georgia

  • KBC Zagreb

    Zagreb, HR-10 000, Croatia

  • University Hospital of Split

    Split, 21 000, Croatia

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