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

Study Overview
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Brief Summary
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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.

Official Title
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An Observational Post-marketing Study for Evaluation of Ongoing Safety and Effectiveness of Catheter Mapping and Ablation Using Commercially Approved BWI Medical Devices for the Treatment of Patients With Cardiac Arrhythmias

Conditions
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Cardiac Arrhythmias

Intervention / Treatment
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* Device: BWI Medical Device


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants Diagnosed with Cardiac Arrhythmias<br>Patients diagnosed with cardiac arrhythmias who are scheduled to undergo an ablation procedure in routine clinical practice for management of their arrhythmia with a BWI therapeutic catheter will be observed. | Device: BWI Medical Device<br>* Participants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, 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 (permanent); 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 (permanent), aggravation or new onset heart failure, coronary artery injury, aortic dissection and valve injury. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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 | Number of participants with elimination of all targeted late potentials and local abnormal ventricular activation (LAVAs) at end of procedure will be reported. | Up to 7 Days | 
| AF: Number of Participants with Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes | Number of participants with documented (symptomatic and asymptomatic) AF, AT, AFL episodes (episodes greater than or equal to [>=] 30 seconds) post-blanking will be reported. | From Day 91 to Day 365 (post-blanking) | 
| AF: Number of Participants with Documented Symptomatic AF, AT, AFL Episodes | Number of participants with documented symptomatic AF, AT, AFL episodes (episodes >= 30 seconds) post-blanking will be reported. | 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. | 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. | From Day 91 to Day 365 (post-blanking) | 
| AF: Change in AF Burden Compared to Baseline for Participants with Implantable Arrhythmia Monitoring Device | AF burden will be measured as the change in the percentage of time that participants will be in AF (symptomatic and asymptomatic) compared to baseline will be calculated. The change in AF burden for the overall study population will be calculated and expressed. | Baseline, Day 91 up to Day 365 | 
| SVT: Number of Participants with Recurrence of Documented Arrhythmia of the Targeted SVT | Number of participants with recurrence of documented arrhythmia of the targeted SVT (episodes >=30 seconds) will be reported. | From Day 1 to Day 365 | 
| SVT: Number of Participants with Documented Arrhythmia of new SVT, not Targeted During Index Procedure | Number of participants with documented arrhythmia of new SVT, not targeted during index procedure will be reported. | From Day 1 to Day 365 | 
| SVT: Number of Participants with Repeated Ablation | Number of participants with repeated ablation will be reported. | From Day 1 to Day 365 | 
| SVT: Change in Study Arrhythmia Burden Compared to Baseline for Participants with Implantable Arrhythmia Monitoring Device | Study arrhythmia burden will be measured as the change in the percentage of time that participants will be in study arrhythmia (symptomatic and asymptomatic) compared to baseline will be calculated. The change in study arrhythmia for the overall study population will be calculated and expressed. | From Day 1 to Day 365 | 
| VT: Number of Participants with Recurrence of Documented Arrhythmia of the Clinically Relevant/Targeted VT | Number of participants with recurrence of documented arrhythmia of the clinically relevant/targeted VT (episodes >=30 seconds) will be reported. | From Day 1 to Day 365 | 
| VT: Number of Participants with Documented Arrhythmia of new VT, not Targeted During Index Procedure | Number of participants with documented arrhythmia of new VT, not targeted during index procedure will be reported. | From Day 1 to Day 365 | 
| VT: Number of Participants with Repeated Ablation | Number of participants with repeated ablation will be reported. | From Day 1 to Day 365 | 
| VT: Number of Participants with All Cause and Cardiac Mortality | Number of participants with all cause and cardiac mortality will be reported. | Up to Day 365 | 
| VT: Number of Participants with Heart Failure Hospitalization | Number of participants with heart failure hospitalization will be reported. | Up to Day 365 | 
| VT (For Participants with Continuous Arrhythmia Monitoring): Number of Participants with PVC Burden | Number of participants with PVC burden for participants with continuous arrhythmia monitoring will be reported based on criterias such as % PVC beats/total beats and at least 80% reduction in PVC burden. | Up to Day 365 | 
| VT (For Participants with Implantable Arrhythmia Monitoring): Number of Participants with VT Burden | Number of participants with VT burden for participants with implantable arrhythmia monitoring will be reported based on criterias such as implantable cardioverter defibrillator (ICD) shocks (appropriate and inappropriate), appropriate antitachycardia pacing therapy (ATP), VT episodes and at least 75% reduction in VT burden. | Up to Day 365 |