Sphere-9 PAF China Study

Prior treatment

• Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
• Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
• Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy
• Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
• Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
• Known drug or alcohol dependency
• Treatment with Amiodarone within the 3 months prior to enrollment

Other illness

• Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
• Presence of a permanent pacemaker, biventricular pacemaker, , or any type of implantable cardiac defibrillator (with or without biventricular pacing function), , or presence of a loop recorder or insertable cardiac monitor (ICM) that has not reached manufacturer-defined end of service (or equivalent end-of-life state)
• Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date
• Unstable angina
• Severe lung disease, primary pulmonary hypertension, or any lung disease with abnormal blood gases or requiring supplemental oxygen
• Rheumatic heart disease
• Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder
• Active systemic infection or sepsis
• History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
• Known allergies or hypersensitivities to adhesives
• Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
• Amyloid heart disease (cardiac amyloidosis)

Lab values

• NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 40% measure by acceptable cardiac testing (e.g. TTE), or planned transplant or left ventricular assist device (LVAD)
• Renal insufficiency with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2, or any history of renal failure requiring dialysis or renal transplant

Other

• Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration \> 7 days
• AF that required three (3) or more distinct cardioversions in the preceding 12 months.
• LA anteroposterior \> 5.0 cm (by MRI, CT, or TTE)
• Presence of any pulmonary vein stents
• Known pre-existing pulmonary vein stenosis
• Pre-existing hemidiaphragmatic paralysis
• Moderate to severe aortic or mitral valve stenosis
• Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR)
• Contraindication to or unwillingness to use systemic anticoagulation
• Documented left atrial thrombus on imaging
• Hypertrophic cardiomyopathy
• Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
• Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date
• Carotid stenting or endarterectomy
• Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
• Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed
• Body mass index \> 40 kg/m2
• Atrial myxoma
• Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
• Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results.

• Failure of, intolerance to, or contraindication to at least one Class I-IV AAD for the treatment of PAF, as evidenced by recurrent symptomatic AF. A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following:
  • a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and
  • at least 1 electrocardiographically documented episode within 12 months prior to enrollment
• Adults who are ≥18 and ≤80 years of age on the day of enrollment.
• Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.