RecruitingNot Applicable

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

United States360 participantsStarted 2025-09-10

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients between the ages of 18 and 80 years, or older than 18 if required by local law.
✓. Diagnosis of drug refractory, recurrent, paroxysmal or persistent AF:
✓. 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.
✓. Life expectancy \>1 year.

✕. 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.
✕. 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).
✕. New York Heart Association (NYHA) Class III or IV.
✕. 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.
✕. 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.

Safety: Number of Participants With at Least One Primary Safety Event.

Timeframe: Up to 180 days

Effectiveness: Number of Participants With Treatment Success.

Timeframe: Up to 12 months

NCT IDNCT06784466

SponsorArga Medtech SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Steven McQuillan, BA

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients between the ages of 18 and 80 years, or older than 18 if required by local law.
✓. Diagnosis of drug refractory, recurrent, paroxysmal or persistent AF:
✓. 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.
✓. Life expectancy \>1 year.

✕. 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.
✕. 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).
✕. New York Heart Association (NYHA) Class III or IV.
✕. 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.
✕. 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.