Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorArga Medtech SA
About this trial
To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
Eligibility criteria
Qualifiers
Patients between the ages of 18 and 80 years, or older than 18 if required by local law.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Treatment groups
360 Participants
are divided into 2 treatment groupsLocations
27Belgium
AZorg Aalst9300, Aalst Belgium
Jessa Ziekenhuis3500, Hasselt Belgium
Croatia
KBC SplitHR 21000, Split Croatia
KBC Zagreb10000, Zagreb Croatia
Sponsors and collaborators
Arga Medtech SA
Lead sponsor
Source ClinicalTrials.gov