Study of the Argá Medtech CSE Ablation System for Atrial Fibrillation
This study is testing a new device called the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System for people with atrial fibrillation (AF), a condition where the heart beats irregularly. The goal is to see how safe and effective this ablation system is at treating AF. You might be able to join if you are between 18 and 80 years old and have paroxysmal AF (AF that comes and goes) or persistent AF (AF that lasts longer) that hasn't responded well to medications. The study will measure safety by looking at any problems that happen within 180 days, and effectiveness by seeing how many people have successful treatment after 12 months. The study is currently enrolling about 360 participants.
- Study design
- This is a multi-center study that is not randomized or blinded, meaning participants will know they are receiving the Argá Medtech CSE Ablation System. It aims to enroll 360 participants.
- What's involved
- Participants will undergo an ablation procedure using the Argá Medtech CSE Ablation System. Safety will be monitored for up to 180 days, and effectiveness will be assessed for up to 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety up to 180 days and for effectiveness up to 12 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
At a glance
Conditions
NCT06784466
Where you'd take part
This study runs at 27 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Advent Health
Orlando, Floridastudy coordinator listed
Recruiting
Arrhythmia Research Group
Jonesboro, Arkansasstudy coordinator listed
Recruiting
Ascension / St. Vincent's Jacksonville
Jacksonville, Floridastudy coordinator listed
Recruiting
AZorg Aalst
Aalst, Belgiumstudy coordinator listed
Recruiting
Banner University Med Ctr
Phoenix, Arizonastudy coordinator listed
Recruiting
Baptist Health Lexington
Lexington, Kentuckystudy coordinator listed
Recruiting
Cleveland Clinic
Cleveland, Ohiostudy coordinator listed
Recruiting
Emory
Atlanta, Georgiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Safety: Number of Participants With at Least One Primary Safety Event.Up to 180 days
Primary safety events are: Within 7 days of the index procedure: * Complete heart block * Coronary spasm * Myocardial infarction * Peripheral or organ thromboembolism * Stroke * Transient ischemic attack * Unresolved phrenic nerve palsy * Vascular access complications * Pericarditis Within 30 days of the index procedure: * Acute renal failure * Cardiac tamponade / perforation * Cardiovascular or pulmonary Pulsed Field Ablation (PFA)-related hospitalization * Death * Gastroparesis * Major bleeding Within180 days of the index procedure: * Pulmonary vein stenosis (≥70% diameter reduction) * Esophageal perforating complications
- Effectiveness: Number of Participants With Treatment Success.Up to 12 months
Treatment success is defined as freedom from treatment failure. 1. Acute Procedural Success and 2. Chronic Success: * Documented atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) on a 12-lead electrocardiogram (ECG), event monitor, or Holter monitor after the 90-day Blanking Period * Re-ablation in the left atrium for AF, AFL, or AT * Any electrical cardioversion for AF, AFL, or AT * Any Class I or III antiarrhythmic (AAD) dose increase from the historic maximum ineffective dose prior to the Index Procedure or initiation of any new Class I or III AAD.