Dipole Density Mapping in Supraventricular Tachycardia

The research study was conducted in multiple countries throughout the EU and Canada. The protocol and their corresponding NCT numbers are as follows:

NCT01914549 (Protocol CL-SVT-001, Site Belgium, Bruges Dr. Duytschaever = PI) NCT01875614 (Protocol CL-SVT-002, Sites in the UK, Drs. Grace, Hall, & Schilling = PIs) NCT03368781 (Protocol CL-SVT-004, Site Hamburg, Germany Prof. Willems = PI) NCT02469623 (Protocol CL-SVT-005, Site Prague, Czech Republic Prof. Neuzil = PI) NCT02469636 (Protocol CL-SVT-006, Site Santiago, Chile Dr. Bittner = PI) NCT02469649 (Protocol CL-SVT-008, Site Ontario, Canada Dr. Verma = PI)

All of the above records were combined into one as all protocols were essentially identical and one study report was written that encompasses the data/results for all protocols.

Inclusion criteria

• Be aged 18-75 years
• Be scheduled for ablation of an SVT due to the arrhythmia being recurrent, poorly tolerated, and /or unable to be controlled with antiarrhythmic drugs.
• Be able and willing to give informed consent

Exclusion criteria

• Have any of the following:

• implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped
• permanent pacemaker or ICD leads in the chamber being mapped
• hypercoagulopathy or an inability to tolerate anticoagulation during the procedure
• Stents in the area of the pulmonary veins (Study CL-SVT-004 ONLY)
• MI within the prior two (2) months
• Cardiac surgery within the prior three (3) months
• Intracardiac thrombus
• Clinically significant tricuspid and/or mitral valve regurgitation or stenosis
• Cerebral ischemic event (including TIA) in the prior six (6) months
• Pregnant or nursing
• Currently enrolled in another clinical investigation
• Have a contraindication for transfemoral venous access (Study CL-SVT-004 ONLY)
• Have a contraindication for transseptal left atrial access (for patients with left atrial arrhythmias) (Study CL-SVT-004 ONLY)
• Life expectancy of less than one (1) year (Study CL-SVT-004 ONLY)
• Any health condition that, in the Investigator's opinion, would not allow the application of the investigational device (Study CL-AF-004 ONLY)

NOTE: The additional exclusion criteria for CL-SVT-004 were not expected to alter or bias the patient selection for study enrollment. While these criteria would have been assumed by other investigators as a standard of care for safe enrollment in a clinical study, the German EC approval required the additional statements.