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.
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
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
Study population consists of participants diagnosed with cardiac arrhythmias who are scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined Biosense Webster Inc (BWI) therapeutic catheter.
Cohort
Prospective
BWI Medical Device
DeviceParticipants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study.
Varipulse Catheter
DeviceParticipants treated with Varipulse Catheter in the main study will be part of the VARIPURE sub-study. No specific intervention will be observed for this study.
Dual Energy THERMOCOOL SMARTTOUCH SF Catheter
DeviceParticipants treated with the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter in the main study will be part of the DUACURE sub-study. No specific intervention will be observed for this study.
Number of Participants with Primary Adverse Events (PAEs) Related to Device in Scope and/or Study Procedure Within 7 Days of the Initial Study Procedure
PAEs in participants with Atrial Fibrillation (AF) and for SupraVentricular Tachycardia (SVT) includes device or procedure related death, atrio-esophageal fistula/ esophageal perforation , severe pulmonary vein stenosis, cardiac tamponade/perforation, thromboembolism, pericarditis, stroke/cerebrovascular accident, transient ischemic attack, phrenic nerve paralysis (permanent), myocardial infarction, major vascular access complication/bleeding, heart block; PAEs in participants with Ventricular Tachycardia (VT) includes device or procedure related death, cardiac tamponade/perforation, thromboembolism, pericarditis, stroke/cerebrovascular accident, transient ischemic attack, phrenic nerve paralysis (permanent), myocardial infarction, major vascular access complication/bleeding, heart block, aggravation or new onset heart failure, coronary artery injury, aortic dissection and valve injury.
AF: Number of Participants with Isolation of all Targeted Pulmonary Veins
Number of Participants with isolation (entrance block confirmation) of all targeted pulmonary veins will be reported.
SVT (Sinus Nodal Re-entrant Tachycardia, Focal AT, Multifocal AT, AVNRT, Non Re-entrant Junctional Tachycardias): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure
Number of participants with sinus nodal re-entrant tachycardia, focal atrial tachycardia (AT) multifocal AT, atrioventricular nodal reentry tachycardia (AVNRT), non re-entrant junctional tachycardias with non-inducibility of the targeted tachycardia at end of procedure will be reported.
SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line
Number of participants with Macro Re-entrant Atrial Tachycardia (MRAT) with complete bidirectional conduction block across the ablation line will be reported.
Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])
Number of participants with device and/or procedure-related Serious Adverse Events (SADEs) within 7 days (early-onset), \>7-30 days (peri-procedural) and \>30 days (late onset) following the initial study procedure will be reported.
Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs])
Number of participants with device and/or procedure-related non-serious adverse events (Non-serious ADEs) within 7 days (early-onset), \>7-30 days (peri-procedural) and \>30 days (Late Onset) following the initial study procedure will be reported.
AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs)
Number of participants with Acute reconnection among all targeted PVs will be reported.
SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure
Number of participants with MRAT with non-inducibility of the targeted tachycardia at end of procedure will be reported.
VARIPURE sub-study: Number of Participants With Coronary Spasm During Ablation
Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with coronary spasm during ablation will be reported.
VARIPURE Sub-Study: Number of Participants With Vagal Response During Ablation
Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with vagal response during ablation will be reported.
VARIPURE Sub-Study: Number of Participants With Acute Kidney Failure Post Ablation
Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with acute kidney failure post ablation will be reported.
DUACURE Sub-Study: Number of Participants With Coronary Spasm During Ablation
Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with coronary spasm during ablation will be reported.
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