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

Biosense Webster, Inc.8,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

8,000

Conditions

Arrhythmias, Cardiac

Interventions

BWI Medical DeviceDEVICE

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

Dual Energy THERMOCOOL SMARTTOUCH SF CatheterDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion criteria * 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 Exclusion criteria: * 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

Locations (46)

Medical University of Graz

Graz, Austria

RECRUITING

Ordensklinikum Linz GMBH

Linz, Austria

RECRUITING

Universitätsklinikum Wiener Neustadt

Wiener Neustadt, Austria

RECRUITING

OLV Aalst

Aalst, Belgium

Outcomes

Primary Outcomes

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.

Time frame: Up to 7 Days

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.

Time frame: Up to 7 Days

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.

Time frame: Up to 7 Days

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.

Time frame: Up to 7 Days

SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway

Number of participants with atrioventricular reentry tachycardia (AVRT) with complete block of accessory pathway will be reported.

Time frame: Up to 7 Days

VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure

Number of participants with non-inducibility of the targeted ischemic or non-ischemic VT at end of procedure will be reported.

Time frame: Up to 7 days

VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT

Number of participants with elimination of clinically relevant idiopathic VT will be reported. Clinically relevant: any spontaneous VT or any induced VT.

Time frame: Up to 7 days

VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs)

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.

Time frame: Up to 7 days

Secondary Outcomes

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.

Time frame: Up to 365 Days

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.

Time frame: Up to 365 Days

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.

Time frame: Up to 7 Days

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.

Time frame: Up to 7 Days

SVT (AVNRT): Number of Participants with Elimination or Modification of Slow Pathway Conduction

Number of participants with AVNRT with elimination or modification of slow pathway conduction will be reported.

Time frame: Up to 7 Days

VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of any VT at end of Procedure

Number of participants with non-inducibility of any VT (Ischemic or Non-ischemic) at end of procedure will be reported.

Time frame: Up to 7 Days

VT (Ischemic or Non-ischemic): Number of Participants with Elimination of all Targeted Late Potentials and Local Abnormal Ventricular Activation (LAVAs) at end of Procedure

Central Contacts

Nathalie Macours

CONTACT

+32 479 97 05 05 nmacours1@its.jnj.com

Liesbeth Gorissen

CONTACT

LGORISSE@ITS.JNJ.com

AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes

Number of participants with freedom from documented (symptomatic and asymptomatic) AF, AT, AFL episodes (episodes greater than or equal to \[\>=\] 30 seconds) post-blanking will be reported.

Time frame: From Day 91 to Day 365 (post-blanking)

AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes

Number of participants with freedom from documented symptomatic AF, AT, AFL episodes (episodes \>= 30 seconds) post-blanking will be reported.

Time frame: From Day 91 to Day 365 (post-blanking)

AF: Number of Participants with Repeated Ablation

Number of participants with repeated ablation post-blanking will be reported.

Time frame: From Day 91 to Day 365 (post-blanking)

AF: Number of Participants with Repeated Ablation with Pulmonary Vein (PV) Reconnection

Number of participants with repeated ablation with PV reconnection post blanking will be reported.

Time frame: From Day 91 to Day 365 (post-blanking)

SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT

Number of participants with freedom from documented arrhythmia of the primary SVT (episodes \>=30 seconds) will be reported.