An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias

Condition(s) studied

Investigational drug(s) / intervention(s)

BWI Medical Device: Participants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study.

Varipulse Catheter: Participants 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: Participants 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.

Study summary

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

Primary outcome measure(s)

• 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 — Up to 7 Days
  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 — Up to 7 Days
  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 — Up to 7 Days
  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 — Up to 7 Days
  Number of participants with Macro Re-entrant Atrial Tachycardia (MRAT) with complete bidirectional conduction block across the ablation line will be reported.
• SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway — Up to 7 Days
  Number of participants with atrioventricular reentry tachycardia (AVRT) with complete block of accessory pathway will be reported.
• VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure — Up to 7 days
  Number of participants with non-inducibility of the targeted ischemic or non-ischemic VT at end of procedure will be reported.
• VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT — Up to 7 days
  Number of participants with elimination of clinically relevant idiopathic VT will be reported. Clinically relevant: any spontaneous VT or any induced VT.
• VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs) — Up to 7 days
  Number of participants with elimination of clinically relevant idiopathic PVCs will be reported. Clinically relevant: any spontaneous PVC or any induced PVC; prior to treatment, PVCs would be deemed clinically relevant if they are present greater than (\>) 20 percent (%) of daily heartbeat.

Trial sites (46)

+ 6 more sites — see the full list on the official registry below.

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