DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

Prior treatment

• At time of enrollment and/or prior to procedure:
• LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment
• Sepsis, active systemic infection or fever (\>100.5 oF / 38 oC) within a week prior to the ablation procedure
• Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
• Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.
• Life expectancy \<12 months based on medical history or the medical judgement of the investigator.
  • Within 1 month of enrollment or just prior to procedure:
• Implant procedure performed for ICD, CRT leads or pacemaker

Other illness

• AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause
• Rheumatic heart disease
• Currently NYHA Class III or IV or exhibits uncontrolled heart failure
• Coagulopathy, bleeding diathesis or suspected procoagulant state
• Significant restrictive or obstructive pulmonary disease or chronic respiratory condition
• Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the subject or deem the subject inappropriate to participate in the study.
• Acute or chronic medical condition that in the judgment of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study.
• Myocardial infarction (MI), unstable angina, cardiac surgery or coronary intervention
  • Within 6 months of enrollment:
• Documented stroke, CVA, TIA or suspected neurological event

Lab values

• Left ventricular ejection fraction (LVEF) \<40%
• Creatinine \>2.5mg/dl or creatinine clearance \<30mL/min
  • Within 3 months of enrollment:

Other

• Continuous AF \>12 months (long-standing persistent AF)
• Paroxysmal AF with longest episode \<7 days
• Severe mitral regurgitation
• Hypertrophic cardiomyopathy
• LA diameter \>5.5 cm
• Body Mass Index (BMI) \>42 kg/m2.
• Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation
• Positive pregnancy test results for female subjects of childbearing potential or breast feeding.
• Documented LA thrombus upon imaging
• Significant gastrointestinal (GI) bleed
• Coronary artery bypass graft (CABG) procedure

• Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
• Subjects with a history of documented symptomatic, persistent Atrial Fibrillation with 1) a physician's note documenting a continuous AF episode lasting longer than 7 days but less than 12 months AND 2) two electrocardiograms from any form of rhythm monitoring showing continuous AF taken at least 7 days apart OR a 24-hour Holter within 180 days of the ablation procedure showing continuous AF.
• Refractory, intolerant or contraindicated to at least one Class I or III anti-arrhythmic (AAD) drug.
• Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
• Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.
• Subject is willing and able to provide written consent.