RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)

Exclusion Criteria16

• Prothrombotic or bleeding tendency due to coagulopathy or blood dyscrasia
• Inability to tolerate heparin therapy (e.g. heparin induced thrombocytopenia, allergy, etc.)
• Prosthetic or stenotic valves in the chamber where the intended mapping will occur, or in the path of the catheter access route
• Active systemic infection or sepsis
• Hemodynamic instability or shock at baseline precluding ablation in the assessment of the investigator.
• Presence of intracardiac thrombus, tumor, or other abnormality which precludes catheter introduction
• Women who are pregnant or lactating
• Cardiac surgery within the past 90 days
• Acute myocardial infarction within 3 months
• Stable/unstable angina or ongoing myocardial ischemia
• Subjects with an active heart failure decompensation
• Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes
• Congenital heart disease with or without corrective surgery that would complicate a mapping procedure
• Subjects having untreatable allergy to contrast media
• Vascular pathology or tortuosity precluding standard vascular access techniques
• Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.