Using a new electroporation system to treat atrial fibrillation
Coherent Sine Burst (CSE) Electroporation System Pilot Study in Patients with Atrial Fibrillation
This study is testing a new treatment system for people with atrial fibrillation to see if it safely helps improve their heart rhythm.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Arga Medtech SA Industry-sponsored |
| Locations | 3 sites (Split and 2 other locations) |
| Trial ID | NCT05572047 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and effectiveness of the Arga Medtech Coherent Sine-Burst Electroporation System for patients with atrial fibrillation. It is a prospective, single-arm, multi-center, and multi-national study that aims to gather clinical data supporting the use of this system for pulmonary vein isolation and additional ablation procedures. Patients with paroxysmal or persistent atrial fibrillation will undergo treatment, followed by remapping at 90 days to assess the durability of the ablation. Follow-up evaluations will occur at various intervals post-procedure to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals scheduled for ablation of paroxysmal or persistent atrial fibrillation who have failed at least one antiarrhythmic drug.
Not a fit: Patients with contraindications to ablation or those with a history of certain cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and safer treatment option for patients suffering from atrial fibrillation.
How similar studies have performed: While this approach is novel, similar studies have shown promise in the use of advanced ablation techniques for atrial fibrillation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Split and 2 other locations
- University Hospital of Split — Split, Croatia (Recruiting)
- KBC Zagreb — Zagreb, Croatia (Recruiting)
- Israeli-Georgian Medical Research Clinic Helthycore Ltd — Tbilisi, Georgia (Active_not_recruiting)
Study contacts
- Principal investigator: Ante Anic, MD — University Hospital of Split
- Study coordinator: David Neale
- Email: david@argamedtech.com
- Phone: +41(0)767792117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.