Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter
2012年3月1日 更新者：Biosense Webster, Inc.
Navistar Thermocool Evaluation of the Catheter With the Stockert 70 Radiofrequency Generator for Endocardial Ablation in Patients With Typical Atrial Flutter
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
研究概览
详细说明
This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation.
The device is currently FDA approved for commercial distribution.
Subjects with symptomatic typical atrial flutter will be considered for the condition of approval study.
This study will be conducted at up to 30 centers in a minimum of 221 evaluable subjects.
研究类型
介入性
注册 (实际的)
291
阶段
- 第四阶段
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
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama, Birmingham
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Arizona
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Scottsdale、Arizona、美国、85251
- Arizona Arrhythmia Consultants
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California
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Los Angeles、California、美国、90017
- Good Samaritan Hospital
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Santa Monica、California、美国、90404
- Pacific Heart Institute
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Florida
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Gainsville、Florida、美国、32611
- University of Florida
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Hollywood、Florida、美国、33031
- Memorial Regional Hospital
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Orlando、Florida、美国、32803
- Florida Hospital
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Illinois
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Chicago、Illinois、美国、60637
- University of Chicago
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Indiana
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Indianapolis、Indiana、美国、46060
- The Care Group LLC, St. Vincent Hospital and Health Care Center, Inc.
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Kentucky
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Lexington、Kentucky、美国、40503
- Central Baptist Hospital
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Maine
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Portland、Maine、美国、04102
- Maine Medical Center
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Maryland
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Baltimore、Maryland、美国、21201
- University of Maryland
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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Michigan
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Detroit、Michigan、美国、48236
- St. John Hospital and Medical Center
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Minnesota
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Minneapolis、Minnesota、美国、55416
- Park Nicollet Institute
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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Oklahoma
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Oklahoma City、Oklahoma、美国、73104
- University of Oklahoma, Health Sciences Center
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
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South Carolina
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Charleston、South Carolina、美国、29425
- Medical University of South Carolina
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Texas
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Houston、Texas、美国、77030
- Texas Heart Institute
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Vermont
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Burlington、Vermont、美国、05401
- University of Vermont, College of Medicine
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Virginia
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Falls Church、Virginia、美国、22042
- Inova Research Center
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Richmond、Virginia、美国、23219
- Virginia Commonwealth University
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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:
- Two symptomatic episodes of typical atrial flutter (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFL occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFL tachyarrhythmia, including atrial fibrillation.
- At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device within 6 months prior to enrollment.
- 18 years of age or older
- Informed consent
Exclusion Criteria:
- Intracardiac thrombus
- Uncontrolled heart failure, or New York Heart Association (NYHA) class III or IV heart failure
- Women who are pregnant
- Cardiac surgery (ventriculotomy or atriotomy) within the past two months
- Intra-atrial thrombus, tumor, or other abnormality that precludes catheter introduction and placement
- Unstable angina or acute myocardial infarction within 3 months
- Awaiting cardiac transplantation
- Heart disease in which corrective surgery is anticipated within 6 months
- Presence of condition that precludes appropriate vascular access
- Enrolled in any investigational device exemption (IDE) investigating study for a device or drug
- High risk for non-compliance with the protocol (e.g., inaccessible for follow-up by the investigator or patient's physician)
- Radio frequency (RF) ablation for typical atrial flutter within the past 2 months
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：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Navistar ThermoCool Catheter
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Navistar ThermoCool catheter
其他名称：
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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 |
|---|---|---|
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Percentage of Subjects With Complete Bidirectional Conduction Block.
大体时间：During the procedure
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Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus.
The percentage of subjects with confirmed conduction block will serve as the outcome measure.
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During the procedure
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Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure.
大体时间：7 Days
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The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study.
A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death.
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7 Days
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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。
调查人员
- 首席研究员：Warren Jackman, M.D.、University of Oklahoma
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
2006年1月1日
初级完成 (实际的)
2007年9月1日
研究完成 (实际的)
2008年2月1日
研究注册日期
首次提交
2006年4月25日
首先提交符合 QC 标准的
2006年4月25日
首次发布 (估计)
2006年4月27日
研究记录更新
最后更新发布 (估计)
2012年3月5日
上次提交的符合 QC 标准的更新
2012年3月1日
最后验证
2012年3月1日
更多信息
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.