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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,000
- 试验地点
- 66
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Participants Diagnosed with Cardiac Arrhythmias
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/Varipulse Catheter/ Dual Energy Thermocool Smarttouch surround flow (SF) catheter will be observed.
干预措施: BWI Medical Device (Device)
Participants Diagnosed with Cardiac Arrhythmias
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/Varipulse Catheter/ Dual Energy Thermocool Smarttouch surround flow (SF) catheter will be observed.
干预措施: Varipulse Catheter (Device)
Participants Diagnosed with Cardiac Arrhythmias
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/Varipulse Catheter/ Dual Energy Thermocool Smarttouch surround flow (SF) catheter will be observed.
干预措施: Dual Energy THERMOCOOL SMARTTOUCH SF Catheter (Device)
结局指标
主要结局
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
时间窗: 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.
SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway
时间窗: Up to 7 Days
Number of participants with atrioventricular reentry tachycardia (AVRT) with complete block of accessory pathway will be reported.
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs)
时间窗: 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.
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
时间窗: 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.
AF: Number of Participants with Isolation of all Targeted Pulmonary Veins
时间窗: Up to 7 Days
Number of Participants with isolation (entrance block confirmation) of all targeted pulmonary veins will be reported.
SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line
时间窗: 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.
VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of the Targeted VT at end of Procedure
时间窗: 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
时间窗: 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.
次要结局
- SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure(Up to 7 Days)
- Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])(Up to 365 Days)
- Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs])(Up to 365 Days)
- AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs)(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(Up to 7 Days)
- AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes(From Day 91 to Day 365 (post-blanking))
- AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes(From Day 91 to Day 365 (post-blanking))
- AF: Number of Participants with Repeated Ablation(From Day 91 to Day 365 (post-blanking))
- AF: Number of Participants with Repeated Ablation with Pulmonary Vein (PV) Reconnection(From Day 91 to Day 365 (post-blanking))
- SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT(From Day 1 to Day 365)
- SVT: Number of Participants with Freedom From Documented Arrhythmia of new SVT, not Targeted During Index Procedure(From Day 1 to Day 365)
- VT: Number of Participants with Freedom From Documented Arrhythmia of the Clinically Relevant/Targeted VT(From Day 1 to Day 365)
- VT: Number of Participants with Freedom From Documented Arrhythmia of new VT, not Targeted During Index Procedure(From Day 1 to Day 365)
- VT: Number of Participants with Repeated Ablation(From Day 1 to Day 365)
- VT: Number of Participants with All Cause and Cardiac Mortality(Up to Day 365)
- VT: Number of Participants with Heart Failure Hospitalization(Up to Day 365)
- SVT (AVNRT): Number of Participants with Elimination or Modification of Slow Pathway Conduction(Up to 7 Days)
- VT (Ischemic or Non-ischemic): Number of Participants with Non-inducibility of any VT at end of Procedure(Up to 7 Days)
- Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])(Up to 365 Days)
- Number of Participants with Device and/or Procedure-Related Non-Serious Adverse Events (Non-Serious Adverse Device Effects [ADEs])(Up to 365 Days)
- AF: Number of Participants with Acute Reconnection Among all Targeted Pulmonary Veins (PVs)(Up to 7 Days)
- SVT (MRAT): Number of Participants with Non-inducibility of the Targeted Tachycardia at end of Procedure(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(Up to 7 Days)
- AF: Number of Participants with Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes(From Day 91 to Day 365 (post-blanking))
- AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes(From Day 91 to Day 365 (post-blanking))
- AF: Number of Participants with Repeated Ablation(From Day 91 to Day 365 (post-blanking))
- AF: Number of Participants with Repeated Ablation with Pulmonary Vein (PV) Reconnection(From Day 91 to Day 365 (post-blanking))
- SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT(From Day 1 to Day 365)
- SVT: Number of Participants with Freedom From Documented Arrhythmia of new SVT, not Targeted During Index Procedure(From Day 1 to Day 365)
- SVT: Number of Participants with Repeated Ablation(From Day 1 to Day 365)
- VT: Number of Participants with Freedom From Documented Arrhythmia of the Clinically Relevant/Targeted VT(From Day 1 to Day 365)
- VT: Number of Participants with Freedom From Documented Arrhythmia of new VT, not Targeted During Index Procedure(From Day 1 to Day 365)
- VT: Number of Participants with Repeated Ablation(From Day 1 to Day 365)
- VT: Number of Participants with All Cause and Cardiac Mortality(Up to Day 365)
- VT: Number of Participants with Heart Failure Hospitalization(Up to Day 365)