Using a new electroporation system to treat atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.