Brief 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.

Conditions

• Arrhythmias, Cardiac

Intervention / Treatment

• Device: BWI Medical Device
• Device: Varipulse Catheter
• Device: Dual Energy THERMOCOOL SMARTTOUCH SF Catheter

Primary Outcome Measures

• 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.

Countries

Austria, Belgium, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Portugal, Sweden, Switzerland, United Kingdom

Locations and Investigators

• Medical University of Graz, Graz, Austria (Recruiting)
• Ordensklinikum Linz GMBH, Linz, Austria (Recruiting)
• Universitätsklinikum Wiener Neustadt, Wiener Neustadt, Austria (Recruiting)
• OLV Aalst, Aalst, Belgium (Recruiting)
• AZ Sint-Jan Brugge, Bruges, Belgium (Recruiting)
• CHU Saint-Pierre, Brussels, Belgium (Recruiting)
• UZ Antwerp, Edegem, Belgium (Recruiting)
• Jessa Hospital, Hasselt, Belgium (Recruiting)
• UZ Brussels, Jette, Belgium (Recruiting)
• ASBL CHU HELORA Hôpital de La Louvière site Jolimont, La Louvière, Belgium (Recruiting)
• Aarhus University Hospital, Aarhus, Denmark (Recruiting)
• Rigshospitalet, Copenhagen, Denmark (Recruiting)
• CHU de Clermont-Ferrand, Clermont-Ferrand, France (Recruiting)
• Les Hospices Civils de Lyon, Lyon, France (Recruiting)
• Hôpital Saint Joseph de Marseille, Marseille, France (Recruiting)
• Institut Mutualiste Montsouris, Paris, France (Recruiting)
• CHU de Rennes, Rennes, France (Recruiting)
• Les Hôpitaux Universitaires de Strasbourg, Strasbourg, France (Recruiting)
• Centre Hospitalier Universitaire de Bordeaux, Talence, France (Recruiting)
• Rhön-Klinikum Campus Bad Neustadt, Bad Neustadt an der Saale, Germany (Recruiting)
• Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum, Bad Oeynhausen, Germany (Recruiting)
• Segeberger Kliniken, Bad Segeberg, Germany (Recruiting)
• Oberlausitz-Kliniken, Bautzen, Germany (Recruiting)
• Alfried Krupp Hospital, Essen, Germany (Recruiting)
• Cardioangiologisches Centrum Bethanien (CCB), Frankfurt, Germany (Completed)
• Justus-Liebig-University Giessen, Giessen, Germany (Recruiting)
• Asklepios Klinik Altona, Hamburg, Germany (Recruiting)
• German Heart Centre Munich, Munich, Germany (Recruiting)
• Semmelweis University, Budapest, Hungary (Recruiting)
• Mater Private Heart and Vascular Centre, Dublin, Ireland (Recruiting)
• Shaare Zedek Medical Center, Jerusalem, Israel (Recruiting)
• Tel Aviv Sourasky Medical Center, Tel Aviv, Israel (Completed)
• Ospedale Generale Regionale "F. Miulli", Acquaviva delle Fonti, Italy (Recruiting)
• A.O. Universitaria Delle Marche, Ancona, Italy (Recruiting)
• IRCCS Policlinico San Donato, Milan, Italy (Recruiting)
• Clinica Mediterranea, Naples, Italy (Recruiting)
• Clinical Trial Center Maastricht, Maastricht, Netherlands (Recruiting)
• Erasmus University Medical Center, Rotterdam, Netherlands (Recruiting)
• Haukeland University Hospital, Bergen, Norway (Recruiting)
• Hospital de Santa Cruz, Carnaxide, Portugal (Recruiting)
• Sahlgrenska University Hospital, Gothenburg, Sweden (Recruiting)
• INSELSPITAL Universitätsspital Bern, Bern, Switzerland (Recruiting)
• Glenfield Hospital, Leicester, United Kingdom (Recruiting)
• St. Bartholomew's Hospital, London, United Kingdom (Completed)
• St George's Hospital, London, United Kingdom (Recruiting)
• Royal Brompton Hospital, London, United Kingdom (Recruiting)

Study Officials

• Biosense Webster, Inc. Clinical Trial (Study Director) — Biosense Webster, Inc.