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

Ki vehet részt

• 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

Ki nem vehet részt

• 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