Clinical Evaluation of the StablePoint Catheter and Force Sensing System for Paroxysmal Atrial Fibrillation

Inclusion Criteria

• History of recurrent symptomatic Paroxysmal Atrial Fibrillation (PAF), defined as atrial fibrillation (AF) that terminates spontaneously or with intervention (either procedure or drug therapy) within seven days of onset. Minimum documentation includes the following:

a physician's note indicating recurrent self-terminating atrial fibrillation (AF) which includes at least two symptomatic AF episodes in the patient's history within the last 6 months prior to enrollment, and any electrocardiographically documented AF episode within 12 months prior to enrollment.

• Subjects who are eligible for an ablation procedure for PAF according to 2017 HRS expert consensus statement on catheter ablation of atrial fibrillation;
• Subjects refractory or intolerant to at least one class I or class III antiarrhythmic medication or contraindicated to any class I or class III medications;
• Subjects who are willing and capable of providing informed consent;
• Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center;
• Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

Exclusion Criteria

• Subjects with New York Heart Association (NYHA) Class III or IV heart failure 5.0 cm or left atrial volume >50 ml/m² indexed based on the most recent echocardiography+
• Left ventricular ejection fraction 30 mmHg)
• Presence of left atrial appendage closure device
• Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder
• Subjects who, in the judgment of the investigator, have a life expectancy of less than two (2) years
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion)
• Amiodarone use within 60 days prior to enrollment
• Any carotid stenting or endarterectomy
• Stage 3B renal disease or higher (estimated glomerular filtration rate, eGFR <45 mL/min)
• Known coagulopathy disorder (e.g. von Willebrand's disease, hemophilia)
• Any known contraindication to an AF ablation
• Any known contraindication for anticoagulation (e.g. patients unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation)
• Vena cava embolic protection filter devices and/or known femoral thrombus that prevents catheter insertion from the femoral approach
• Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
• Rheumatic Heart Disease
• Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter
• Subjects unable or unwilling to complete follow-up visits and examinations for the duration of the clinical study
• Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility.
• LVEF and LA diameters obtained ≤180 days prior to enrollment will be acceptable, unless a cardiac event has occurred (e.g. MI) between the date of the exam and the enrollment date. In this case, a new echocardiogram (trans-thoracic or trans-esophageal, or intracardiac echo) must be performed to confirm eligibility prior to performing ablation. If no recent (≤180 days prior to enrollment) echocardiogram is available at the time of the enrollment, a new echocardiogram must be performed either prior to enrolling the patient into the study or post-consent to confirm patient's eligibility prior to performing the ablation. For TTE, LA anteroposterior diameter measured by M-mode from the parasternal long-axis