Home › Trials › NCT06784466

Coherent Sine-Burst Electroporation (CSE) Ablation for Atrial Fibrillation

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

Not applicable Interventional Arga Medtech SA · NCT06784466

This study will test whether the Argá Medtech CSE electroporation device can safely and effectively ablate heart tissue to treat adults with symptomatic paroxysmal or persistent atrial fibrillation who have not responded to drugs.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment360 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorArga Medtech SA Industry-sponsored
Locations27 sites (Birmingham, Alabama and 26 other locations)
Trial IDNCT06784466 on ClinicalTrials.gov

What this trial studies

This is a prospective, multi-center, non-randomized, unblinded pre-market study collecting clinical data to support regulatory approval of the Argá Medtech CSE Ablation System. Adults with drug-refractory, recurrent symptomatic paroxysmal or persistent AF will be enrolled and will undergo at minimum pulmonary vein ablation using the CSE system, with adjunctive atrial ablation allowed per operator judgment. Safety and effectiveness outcomes, including procedure-related events and rhythm outcomes, will be recorded and followed according to the study protocol. The study is designed to generate real-world procedural and clinical data across several U.S. centers.

Who should consider this trial

Good fit: Adults (generally 18–80 years) with symptomatic, drug-refractory paroxysmal or persistent atrial fibrillation who are candidates for pulmonary vein ablation and meet the study's documentation requirements.

Not a fit: Patients with longstanding persistent AF (>1 year), those who are asymptomatic, not candidates for catheter ablation, or who have contraindicating medical conditions are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the device could provide a faster, tissue-selective pulsed-field ablation option that may reduce collateral damage compared with thermal ablation methods.

How similar studies have performed: Other pulsed-field ablation platforms have reported promising safety and efficacy in recent studies, but coherent sine-burst electroporation is a newer variation with limited pre-market clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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.
6. Life expectancy \>1 year.

Exclusion Criteria:

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.
9. Body mass index (BMI) \>40.
10. Patients who have not been on anticoagulation therapy for at least 3 weeks prior to the Index Procedure.
11. Previous cardiac surgery, myocardial infarction, percutaneous coronary intervention or angioplasty (PCI/PTCA) or coronary artery stenting within 3 months prior to enrollment.
12. Symptomatic valvular disease, history of cardiac valve surgery, or prosthetic mitral and tricuspid valve(s).
13. Presence of pulmonary vein abnormalities of stenosis or stenting.
14. Primary pulmonary hypertension.
15. Uncontrolled or untreated hypertension (two measurements of \>180mmHg systolic or \>110 mmHg diastolic at baseline).
16. Pre-existing hemi-diaphragmatic paralysis.
17. Renal insufficiency with an estimated glomerular filtration rate (eGFR) \< 40 mL/min/1.73 m2, or any history of renal dialysis or renal transplant.
18. Rheumatic heart disease.
19. Unstable angina or ongoing myocardial ischemia.
20. Hypertrophic cardiomyopathy, advanced restrictive cardiomyopathy, or severe left ventricular hypertrophy (left ventricular thickness \>15mm).
21. History of blood clotting or bleeding disease (e.g., thrombocytosis).
22. History of documented cerebral infarction, transient ischemic attack, or systemic embolism within 6 months prior to enrollment.
23. Active systemic infection.
24. Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma, or non-metastatic prostate or breast cancer with life expectancy remaining \>1 year).
25. Pregnant or lactating (current or anticipated during study follow-up).
26. Current enrollment in any other clinical study where testing or results from that study may interfere with the procedure or outcomes measurement for this study.
27. Any other condition that, in the judgment of the Investigator, makes the patient:

    1. Unlikely to benefit from an AF ablation procedure (e.g., advanced infiltrative cardiomyopathies, severe mitral stenosis or regurgitation, and/or cor pulmonale, etc.), or
    2. A poor candidate for the study (e.g., vulnerable patient population, mental illness, addictive disease, terminal illness, and extensive travel away from the research center).

Where this trial is running

Birmingham, Alabama and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atrial FibrillationPersistant Atrial FibrillationParoxysmal AFatrial fibrillationablationcoherent sine-burstelectroporationpulsed field ablation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.