About this trial
The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.
Eligibility criteria
Qualifiers
Diagnosed with paroxysmal or persistent Atrial Fibrillation (AF) or supraventricular tachycardia (SVT) or ventricular tachycardia (VT) and scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined BW therapeutic catheter
Able and willing to comply with all pre, post and follow-up testing and requirements as per hospital standard of care
Signed patient informed consent form (ICF) as applicable per local regulation
Disqualifiers
Currently participating in an interventional (drug, device, biologic) clinical trial
Life expectancy of less than 12-months
Presenting any contraindication for the use of BWI commercially approved medical devices, as indicated in the respective user manuals
Trial design
Treatments tested in this trial
- BWI Medical Device
- Varipulse Catheter
- Dual Energy THERMOCOOL SMARTTOUCH SF Catheter