Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial F… (NCT06784466) | Clinical Trial Compass
RecruitingNot Applicable
Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
United States, Belgium, Croatia360 participantsStarted 2025-09-10
Plain-language summary
To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients between the ages of 18 and 80 years, or older than 18 if required by local law.
. Diagnosis of drug refractory, recurrent, paroxysmal or persistent AF:
. Effectiveness failure of, intolerance to, or a specific contraindication to at least one Class I or III anti-arrhythmic drug.
. Willing and able to give informed consent.
. Willingness, ability, and commitment to participate in baseline, follow-up, and rhythm monitoring evaluations for the full length of the study.
. Life expectancy \>1 year.
Exclusion criteria
. In the opinion of the Investigator, any known contraindication to an AF ablation (including present left atrial \[LA\] thrombus), trans-esophageal echocardiogram (TEE) or computed tomography (CT) scan, or anticoagulation.
. Any duration of continuous AF lasting longer than 12 months.
. History of any previous left atrial ablation or surgical procedure, including prior left atrial appendage closure.
. AF secondary to electrolyte imbalance, thyroid disease, alcohol, or any other reversible or non-cardiac cause.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a new type of ablation technology called Coherent Sine Burst Electroporation — how does this approach differ from the ablation methods already available to me, and what does it mean that it's still being studied in an IDE trial here in the US?
2The trial is measuring how many patients have a 'primary safety event' — what kinds of complications or risks are they specifically watching for with this electroporation system, and how do those compare to the risks of standard catheter ablation?
3Since this is listed as Phase NA, which often applies to device trials, what do we actually know so far about how well and how safely this system has worked in earlier studies or in other countries before it was brought to a US trial?
4I have paroxysmal AF versus persistent AF — does my specific type of atrial fibrillation affect whether this trial might be worth discussing as an option, or is it designed to study both types equally?
5If I were to consider this trial, what would the demands look like in terms of follow-up visits and monitoring, and would enrolling here delay or replace the chance to pursue other proven treatments if the trial results aren't favorable for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety: Number of Participants With at Least One Primary Safety Event.
Timeframe: Up to 180 days
2
Effectiveness: Number of Participants With Treatment Success.
. Left ventricular ejection fraction (LVEF) \< 35% within 6 months of enrollment (e.g. transthoracic echocardiogram (TTE), multiple-gated acquisition (MUGA), magnetic resonance imaging (MRI), nuclear stress test).
. New York Heart Association (NYHA) Class III or IV.
. Left atrial diameter \> 5.0 cm (anteroposterior) within 6 months of enrollment (MRI, CT, TTE, TEE, or physician's note) or non-indexed volume \>100mL if left atrial diameter is not available.
. Current or anticipated implant of a permanent pacemaker, implantable cardioverter or resynchronization device, interatrial baffle, foramen ovale occluder, LA appendage closure, or active implantable/insertable cardiac loop recorder/monitor at the time of the ablation procedure.