Zapping heart rhythm problems: new device uses electrical pulses to treat AFib
NCT ID NCT05572047
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
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2022
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Israeli-Georgian Medical Research Clinic Helthycore Ltd
Tbilisi, 0112, Georgia
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KBC Zagreb
Zagreb, HR-10 000, Croatia
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University Hospital of Split
Split, 21 000, Croatia
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