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使用商业批准的 Biosense Webster (BWI) 医疗器械治疗心律失常参与者的观察性上市后研究 (SECURE)

2026年11月2日 更新者：Biosense Webster, Inc.

一项观察性上市后研究，用于评估使用商业批准的 BWI 医疗设备治疗心律失常患者的导管标测和消融的持续安全性和有效性

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

8000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 丹麦
      • Aarhus、丹麦、8200
        • 招聘中
        • Aarhus University Hospital
      • Copenhagen、丹麦、2100
        • 招聘中
        • Rigshospitalet
  • 以色列
      • Jerusalem、以色列、9103102
        • 招聘中
        • Shaare Zedek Medical Center
      • Tel Aviv、以色列、6423906
        • 完全的
        • Tel Aviv Sourasky Medical Center
  • 匈牙利
      • Budapest、匈牙利、H-1085
        • 招聘中
        • Semmelweis University
  • 奥地利
      • Graz、奥地利、8010
        • 招聘中
        • Medical University of Graz
      • Linz、奥地利、4020
        • 招聘中
        • Ordensklinikum Linz GMBH
      • Wiener Neustadt、奥地利、2700
        • 招聘中
        • Universitätsklinikum Wiener Neustadt
  • 德国
      • Bad Neustadt an der Saale、德国、97616
        • 招聘中
        • Rhön-Klinikum Campus Bad Neustadt
      • Bad Oeynhausen、德国、3245
        • 招聘中
        • Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum
      • Bad Segeberg、德国、23795
        • 招聘中
        • Segeberger Kliniken
      • Bautzen、德国、02625
        • 招聘中
        • Oberlausitz-Kliniken
      • Essen、德国、45131
        • 招聘中
        • Alfried Krupp Hospital
      • Frankfurt、德国、60431
        • 完全的
        • Cardioangiologisches Centrum Bethanien (CCB)
      • Giessen、德国、35390
        • 招聘中
        • Justus-Liebig-University Giessen
      • Hamburg、德国、22763
        • 招聘中
        • Asklepios Klinik Altona
      • Munich、德国、80636
        • 招聘中
        • German Heart Centre Munich
  • 意大利
      • Acquaviva delle Fonti、意大利、70021
        • 招聘中
        • Ospedale Generale Regionale "F. Miulli"
      • Ancona、意大利、60126
        • 招聘中
        • A.O. Universitaria Delle Marche
      • Milan、意大利、20097
        • 招聘中
        • IRCCS Policlinico San Donato
      • Naples、意大利、80122
        • 招聘中
        • Clinica Mediterranea
  • 挪威
      • Bergen、挪威、5021
        • 招聘中
        • Haukeland University Hospital
  • 比利时
      • Aalst、比利时、9300
        • 招聘中
        • OLV Aalst
      • Bruges、比利时、8000
        • 招聘中
        • AZ Sint-Jan Brugge
      • Brussels、比利时、1000
        • 招聘中
        • CHU Saint-Pierre
      • Edegem、比利时、2650
        • 招聘中
        • UZ Antwerp
      • Ghent、比利时、9000
        • 招聘中
        • Maria Middelares
      • Hasselt、比利时、3500
        • 招聘中
        • Jessa Hospital
      • Jette、比利时、1090
        • 招聘中
        • UZ Brussels
      • La Louvière、比利时、7100
        • 招聘中
        • ASBL CHU HELORA Hôpital de La Louvière site Jolimont
  • 法国
      • Clermont-Ferrand、法国、63000
        • 招聘中
        • CHU de Clermont-Ferrand
      • Lyon、法国、69002
        • 招聘中
        • Les Hospices Civils de Lyon
      • Marseille、法国、13285
        • 招聘中
        • Hôpital Saint Joseph de Marseille
      • Paris、法国、75674
        • 招聘中
        • Institut Mutualiste Montsouris
      • Rennes、法国、35033
        • 招聘中
        • CHU de Rennes
      • Strasbourg、法国、67000
        • 招聘中
        • Les Hôpitaux Universitaires de Strasbourg
      • Talence、法国、33404
        • 招聘中
        • Centre Hospitalier Universitaire de Bordeaux
  • 爱尔兰
      • Dublin、爱尔兰、D07 WKW8
        • 招聘中
        • Mater Private Heart and Vascular Centre
  • 瑞典
      • Gothenburg、瑞典、413 45
        • 招聘中
        • Sahlgrenska University Hospital
  • 瑞士
      • Bern、瑞士、03010
        • 招聘中
        • INSELSPITAL Universitätsspital Bern
  • 英国
      • Leicester、英国、LE3 9QP
        • 招聘中
        • Glenfield Hospital
      • London、英国、SW3 6NP
        • 招聘中
        • Royal Brompton Hospital
      • London、英国、SW17 0QT
        • 招聘中
        • St George's Hospital
      • London、英国、EC1A 7BE
        • 完全的
        • St. Bartholomew's Hospital
  • 荷兰
      • Maastricht、荷兰、6229 EV
        • 招聘中
        • Clinical Trial Center Maastricht
      • Rotterdam、荷兰、3015 GD
        • 招聘中
        • Erasmus University Medical Center
  • 葡萄牙
      • Carnaxide、葡萄牙、2790-134
        • 招聘中
        • Hospital de Santa Cruz

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Study population consists of participants diagnosed with cardiac arrhythmias who are scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined Biosense Webster Inc (BWI) therapeutic catheter.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
干预/治疗
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.
设备：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.

设备：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.

设备：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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
大体时间：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.
Up to 7 Days
AF: Number of Participants with Isolation of all Targeted Pulmonary Veins
大体时间：Up to 7 Days

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
大体时间：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.
Up to 7 Days
SVT (MRAT): Number of Participants with Complete Bidirectional Conduction Block Across the Ablation Line
大体时间：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.
Up to 7 Days
SVT (AVRT): Number of Participants with Complete Block of Accessory Pathway
大体时间：Up to 7 Days

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
大体时间：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.
Up to 7 days
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant VT
大体时间：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.
Up to 7 days
VT (Idiopathic): Number of Participants with Elimination of Clinically Relevant Premature Ventricular Contraction (PVCs)
大体时间：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.
Up to 7 days

次要结果测量

结果测量
措施说明
大体时间
Number of Participants with Device and/or Procedure-Related Serious Adverse Events (Serious Adverse Device Effects [SADEs])
大体时间：Up to 365 Days

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])
大体时间：Up to 365 Days

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)
大体时间：Up to 7 Days

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
大体时间：Up to 7 Days

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
大体时间：Up to 7 Days

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
大体时间：Up to 7 Days

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
大体时间：Up to 7 Days

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 Freedom From Documented (Symptomatic and Asymptomatic) AF, AT, Atrial Flutter (AFL) Episodes
大体时间：From Day 91 to Day 365 (post-blanking)

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.
From Day 91 to Day 365 (post-blanking)
AF: Number of Participants with Freedom From Documented Symptomatic AF, AT, AFL Episodes
大体时间：From Day 91 to Day 365 (post-blanking)

Number of participants with freedom from 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
大体时间：From Day 91 to Day 365 (post-blanking)

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
大体时间：From Day 91 to Day 365 (post-blanking)

Number of participants with repeated ablation with PV reconnection post blanking will be reported.
From Day 91 to Day 365 (post-blanking)
SVT: Number of Participants with Freedom From Documented Arrhythmia of the Primary SVT
大体时间：From Day 1 to Day 365

Number of participants with freedom from documented arrhythmia of the primary SVT (episodes >=30 seconds) will be reported.
From Day 1 to Day 365
SVT: Number of Participants with Freedom From Documented Arrhythmia of new SVT, not Targeted During Index Procedure
大体时间：From Day 1 to Day 365

Number of participants with freedom from 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
大体时间：From Day 1 to Day 365

Number of participants with repeated ablation will be reported.
From Day 1 to Day 365
VT: Number of Participants with Freedom From Documented Arrhythmia of the Clinically Relevant/Targeted VT
大体时间：From Day 1 to Day 365

Number of participants with freedom from 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 Freedom From Documented Arrhythmia of new VT, not Targeted During Index Procedure
大体时间：From Day 1 to Day 365

Number of participants with freedom from 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
大体时间：From Day 1 to Day 365

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
大体时间：Up to Day 365

Number of participants with all cause and cardiac mortality will be reported.
Up to Day 365
VT: Number of Participants with Heart Failure Hospitalization
大体时间：Up to Day 365

Number of participants with heart failure hospitalization will be reported.
Up to Day 365

其他结果措施

结果测量
措施说明
大体时间
VARIPURE sub-study: Number of Participants With Coronary Spasm During Ablation
大体时间：Up to Day 365

Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with coronary spasm during ablation will be reported.
Up to Day 365
VARIPURE Sub-Study: Number of Participants With Vagal Response During Ablation
大体时间：Up to Day 365

Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with vagal response during ablation will be reported.
Up to Day 365
VARIPURE Sub-Study: Number of Participants With Acute Kidney Failure Post Ablation
大体时间：Up to Day 365

Ablation procedures using the varipulse medical device will be performed according to the hospital standard practice. Number of participants with acute kidney failure post ablation will be reported.
Up to Day 365
DUACURE Sub-Study: Number of Participants With Coronary Spasm During Ablation
大体时间：Up to Day 365

Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with coronary spasm during ablation will be reported.
Up to Day 365
DUACURE Sub-Study: Number of Participants With Vagal Response During Ablation
大体时间：Up to Day 365

Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with vagal response during ablation will be reported.
Up to Day 365
DUACURE Sub-Study: Number of Participants With Acute Kidney Failure Post Ablation
大体时间：Up to Day 365

Ablation procedures using the duacure medical device will be performed according to the hospital standard practice. Number of participants with acute kidney failure post ablation will be reported.
Up to Day 365

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Biosense Webster, Inc.

调查人员

  • 研究主任：Biosense Webster, Inc. Clinical Trial、Biosense Webster, Inc.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年2月22日

初级完成 (估计的)

2036年12月31日

研究完成 (估计的)

2037年12月31日

研究注册日期

首次提交

2021年2月8日

首先提交符合 QC 标准的

2021年2月8日

首次发布 (实际的)

2021年2月11日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • BWI_2019_05

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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