RecruitingAtrial Fibrillation (AF)Persistant Atrial FibrillationParoxysmal AF

Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation

Eligible age

18–80 yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.

Sponsor: Arga Medtech SA

✓ 1. Patients between the ages of 18 and 80 years, or older than 18 if required by local law.
✓ 2. Diagnosis of drug refractory, recurrent, paroxysmal or persistent AF:
✓ a. Symptomatic paroxysmal AF that is less than 7 days in continuous duration, documented by the following: i. Physician documentation of symptomatic recurrent PAF (2 or more episodes) within 6 months prior to enrollment AND ii. At least 1 documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment.
✓ b. Symptomatic persistent AF that is sustained beyond 7 days and less than 1 year (≥ 7 and ≤ 365 days), documented by the following: i. Physician documentation of at least 1 symptomatic persistent AF episode within 6 months prior to enrollment.
✓ ii. Either a 24-hour continuous ECG recording documenting continuous AF OR 2 ECGs from any regulatory cleared rhythm monitoring device showing continuous AF taken at least 7 days apart, within 6 months prior to enrollment.
✓ 3. Effectiveness failure of, intolerance to, or a specific contraindication to at least one Class I or III anti-arrhythmic drug.
✓ 4. Willing and able to give informed consent.
✓ 5. Willingness, ability, and commitment to participate in baseline, follow-up, and rhythm monitoring evaluations for the full length of the study.

✕ 1. 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.
✕ 2. Any duration of continuous AF lasting longer than 12 months.
✕ 3. History of any previous left atrial ablation or surgical procedure, including prior left atrial appendage closure.
✕ 4. AF secondary to electrolyte imbalance, thyroid disease, alcohol, or any other reversible or non-cardiac cause.
✕ 5. Left ventricular ejection fraction (LVEF) \< 35% within 6 months of enrollment (e.g. transthoracic echocardiogram (TTE), multiple-gated acquisition (MUGA), magnetic resonance imaging (MRI), nuclear stress test).
✕ 6. New York Heart Association (NYHA) Class III or IV.
✕ 7. Left atrial diameter \> 5.0 cm (anteroposterior) within 6 months of enrollment (MRI, CT, TTE, TEE, or physician's note) or non-indexed volume \>100mL if left atrial diameter is not available.
✕ 8. Current or anticipated implant of a permanent pacemaker, implantable cardioverter or resynchronization device, interatrial baffle, foramen ovale occluder, LA appendage closure, or active implantable/insertable cardiac loop recorder/monitor at the time of the ablation procedure.