DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

STUDY INCLUSION CRITERIA- Candidates must meet ALL the following criteria to be enrolled in the DIAMOND-AF study:

• 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 symptomatic, paroxysmal atrial fibrillation (PAF) who have had ≥2 episodes of PAF reported within the 6 months prior to index ablation procedure with a physician note indicating recurrent, self-terminating AF.
• At least one episode of PAF documented by electrocardiographic data within the 12 months prior to index ablation procedure.
• Refractory to at least one Class I-IV AAD for treatment of PAF.
• 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.

STUDY EXCLUSION CRITERIA - Candidates will be excluded from the DIAMOND-AF study if any of the following conditions apply within the following timeframes:

At time of enrollment and/or prior to procedure:

• AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause.
• LA diameter > 5.5 cm.
• LVEF 40 kg/m2.
• LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment.
• Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
• Coagulopathy, bleeding diathesis or suspected procoagulant state
• Sepsis, active systemic infection or fever (>100.5°F / 38°C) within a week prior to the ablation procedure.
• 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.
• 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.
• Positive pregnancy test results for female subjects of childbearing potential or breast feeding.
• Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.
• 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.
• Life expectancy 2.5mg/dl or creatinine clearance 7 days in duration.