Tests a new ablation device for irregular heartbeat from atrial fibrillation

Trial details

Who runs it

Arga Medtech SA

Trial code

NCT06784466

Record updated

15 July 2026

Original description

To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.Read full original descriptionShow less

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

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

Inclusion: 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:; 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; 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; 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; 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.

Exclusion: History of any previous left atrial ablation or surgical procedure, including prior left atrial appendage closure; Patients who have not been on anticoagulation therapy for at least 3 weeks prior to the Index Procedure; Previous cardiac surgery, myocardial infarction, percutaneous coronary intervention or angioplasty (PCI/PTCA) or coronary artery stenting within 3 months prior to enrollment; History of documented cerebral infarction, transient ischemic attack, or systemic embolism within 6 months prior to enrollment; AF secondary to electrolyte imbalance, thyroid disease, alcohol, or any other reversible or non-cardiac cause; New York Heart Association (NYHA) Class III or IV; 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; Symptomatic valvular disease, history of cardiac valve surgery, or prosthetic mitral and tricuspid valve(s); Primary pulmonary hypertension; Uncontrolled or untreated hypertension (two measurements of >180mmHg systolic or >110 mmHg diastolic at baseline); Rheumatic heart disease; Unstable angina or ongoing myocardial ischemia; History of blood clotting or bleeding disease (e.g., thrombocytosis); Active systemic infection; 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); Any other condition that, in the judgment of the Investigator, makes the patient:; Unlikely to benefit from an AF ablation procedure (e.g., advanced infiltrative cardiomyopathies, severe mitral stenosis or regurgitation, and/or cor pulmonale, etc.), or; 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); 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); Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73 m2, or any history of renal dialysis or renal transplant; 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; 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; Body mass index (BMI) >40; Presence of pulmonary vein abnormalities of stenosis or stenting; Pre-existing hemi-diaphragmatic paralysis; Hypertrophic cardiomyopathy, advanced restrictive cardiomyopathy, or severe left ventricular hypertrophy (left ventricular thickness >15mm); Pregnant or lactating (current or anticipated during study follow-up); 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.

ClinicalTrials.gov NCT06784466