此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS

2018年4月16日更新者：Biosense Webster, Inc.

THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Continued Access

This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.

研究概览

地位

完全的

条件

Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation

干预/治疗

设备：THERMOCOOL® SMARTTOUCH™ 导管

详细说明

The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.

研究类型

介入性

注册 (实际的)

148

阶段

第三阶段

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。

学习地点

美国
- Alabama
  - Birmingham、Alabama、美国、35294
    - University of Alabama, Birmingham
- California
  - Stanford、California、美国、94305
    - Stanford University School of Medicine
- Florida
  - Orlando、Florida、美国、32803
    - Florida Hospital
- Georgia
  - Atlanta、Georgia、美国、30309
    - Piedmont Heart Institute
- Illinois
  - Maywood、Illinois、美国、60153
    - Loyola University Chicago
- Kansas
  - Kansas City、Kansas、美国、66160
    - University of Kansas Hospitals
- Maryland
  - Baltimore、Maryland、美国、21287
    - Johns Hopkins Hospital
- Massachusetts
  - Boston、Massachusetts、美国、02115
    - Brigham and Women's Hospital
  - Boston、Massachusetts、美国、02114
    - Massachusetts General Hospital
- Minnesota
  - Minneapolis、Minnesota、美国、55407
    - Abbott Northwestern Hospital
  - Rochester、Minnesota、美国、55902
    - Mayo Clinic
- New Jersey
  - Ridgewood、New Jersey、美国、07450
    - The Valley Hospital
- New York
  - New York、New York、美国、10029
    - Mt. Sinai School of Medicine
- North Carolina
  - Durham、North Carolina、美国、27710
    - Duke University Medical Center
- Ohio
  - Cleveland、Ohio、美国、44195
    - Cleveland Clinic Foundation
  - Columbus、Ohio、美国、43210
    - Ohio State University
- Oklahoma
  - Oklahoma City、Oklahoma、美国、73104
    - University of Oklahoma
- Pennsylvania
  - Philadelphia、Pennsylvania、美国、19104
    - University of Pennslyvania
- Texas
  - Austin、Texas、美国、78705
    - Texas Cardiac Arrhythmia Foundation
- Virginia
  - Richmond、Virginia、美国、23219
    - Virginia Commonwealth University

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

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Have had at least 3 atrial fibrillation episodes within 6 months of this study
Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes
18 years of age or older

Exclusion Criteria including, but not limited to:

Have had previous ablation for atrial fibrillation
Have take amiodarone within 6 months of this study
Have had any heart surgery within the last 60 days
Have had a heart attack within the last 60 days
Females who are pregnant or breast feeding

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

主要用途：治疗
分配：不适用
介入模型：单组作业
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：THERMOCOOL® SMARTTOUCH™ 导管	设备：THERMOCOOL® SMARTTOUCH™ 导管房颤消融

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
Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias 大体时间：Day 91-361	Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures	Day 91-361
Incidence of Primary Adverse Events Within Specified Study Period 大体时间：12 months post procedure	Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block.	12 months post procedure

次要结果测量

结果测量	措施说明	大体时间
Peri-procedural Serious Adverse Events 大体时间：Within 8-30 days post procedure	Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure	Within 8-30 days post procedure
Percentage of Subjects Achieved Acute Effectiveness 大体时间：5 hours of procedure time	Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins	5 hours of procedure time
Late Onset Serious Adverse Events 大体时间：From 31 days post procedure to month 12	Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure	From 31 days post procedure to month 12

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.

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)

2012年7月1日

初级完成 (实际的)

2014年6月1日

研究完成 (实际的)

2014年10月1日

研究注册日期

首次提交

2012年7月10日

首先提交符合 QC 标准的

2012年7月10日

首次发布 (估计)

2012年7月12日

研究记录更新

最后更新发布 (实际的)

2018年5月15日

上次提交的符合 QC 标准的更新

2018年4月16日

最后验证

2018年4月1日

THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS