NCT05572047Completed
Coherent Sine Burst (CSE) Electroporation System Pilot Study in Patients With Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
To evaluate the safety and efficiency of the Arga Medtech CSE Ablation System in the treatment of atrial fibrillation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 101 (actual)
- First submitted
- 5 Oct 2022
- Start date
- 11 Oct 2022
- Primary completion date
- 24 Apr 2026
- Lead sponsor
- Arga Medtech SA
- Diseases
- Atrial fibrillation
- NCT number
- NCT05572047
What you commit to
- Study type: Interventional
- Participants enrolled: 101
- From 11 Oct 2022 to the primary completion date, 24 Apr 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous LA ablation or surgical treatment of AF/AT/AFL
- Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG)
- Previous cardiac valvular surgical or percutaneous procedure or prosthetic valve
- Myocardial infarction within the previous 6 months
- Prior history within the previous 6 months of documented cerebral infarction, TIA or system embolism
Other illness
- AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
- Unstable angina or ongoing myocardial ischemia
- History of blood clotting or bleeding disease
- 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
Lab values
- 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)
Other
- Contraindication to AF ablation, TEE or anticoagulation
- Duration of continuous AF lasting longer than 12 months
- An implanted pacemaker or ICD
- 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
- Hypertrophic cardiomyopathy defined as left ventricular septal wall thickness \> 1.5cm
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Israeli-Georgian Medical Research Clinic Helthycore Ltd Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| University hospital of Split Coordinator of this site? Confirm its status | Split | Croatia | Unknown status |
| KBC Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.