Dipole Density Mapping in Supraventricular Tachycardia (DDRAMATIC-SVT)
Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia
研究概览
详细说明
The research study was conducted in multiple countries throughout the EU and Canada. The protocol and their corresponding NCT numbers are as follows:
NCT01914549 (Protocol CL-SVT-001, Site Belgium, Bruges Dr. Duytschaever = PI) NCT01875614 (Protocol CL-SVT-002, Sites in the UK, Drs. Grace, Hall, & Schilling = PIs) NCT03368781 (Protocol CL-SVT-004, Site Hamburg, Germany Prof. Willems = PI) NCT02469623 (Protocol CL-SVT-005, Site Prague, Czech Republic Prof. Neuzil = PI) NCT02469636 (Protocol CL-SVT-006, Site Santiago, Chile Dr. Bittner = PI) NCT02469649 (Protocol CL-SVT-008, Site Ontario, Canada Dr. Verma = PI)
All of the above records were combined into one as all protocols were essentially identical and one study report was written that encompasses the data/results for all protocols.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Ontario
-
Newmarket、Ontario、加拿大、L3Y 2P9
- Southlake Regional Health Center
-
-
-
-
-
Hamburg、德国、D - 20246
- Elektrophysiologie Universitätsklinikum Hamburg-Eppendorf
-
-
-
-
-
Prague、捷克语、150 30
- Na Homolce Hospital
-
-
-
-
-
Santiago、智利、Región Metropolitana
- Pontificia Universidad Católica de Chile
-
-
-
-
-
Bruges、比利时、8000
- AZ Sint-Jan AV Cardiologie
-
-
-
-
-
Cambridge、英国、CB23
- Papworth Hospital NHS Foundation Trust
-
Liverpool、英国、L14 3PE
- Liverpool Heart and Chest Hospital
-
Whitechapel、英国、E1 1BB
- Barts Health NHS Trust
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- Be aged 18-75 years
- Be scheduled for ablation of an SVT due to the arrhythmia being recurrent, poorly tolerated, and /or unable to be controlled with antiarrhythmic drugs.
- Be able and willing to give informed consent
Exclusion Criteria
Have any of the following:
- implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped
- permanent pacemaker or ICD leads in the chamber being mapped
- hypercoagulopathy or an inability to tolerate anticoagulation during the procedure
- Stents in the area of the pulmonary veins (Study CL-SVT-004 ONLY)
- MI within the prior two (2) months
- Cardiac surgery within the prior three (3) months
- Intracardiac thrombus
- Clinically significant tricuspid and/or mitral valve regurgitation or stenosis
- Cerebral ischemic event (including TIA) in the prior six (6) months
- Pregnant or nursing
- Currently enrolled in another clinical investigation
- Have a contraindication for transfemoral venous access (Study CL-SVT-004 ONLY)
- Have a contraindication for transseptal left atrial access (for patients with left atrial arrhythmias) (Study CL-SVT-004 ONLY)
- Life expectancy of less than one (1) year (Study CL-SVT-004 ONLY)
- Any health condition that, in the Investigator's opinion, would not allow the application of the investigational device (Study CL-AF-004 ONLY)
NOTE: The additional exclusion criteria for CL-SVT-004 were not expected to alter or bias the patient selection for study enrollment. While these criteria would have been assumed by other investigators as a standard of care for safe enrollment in a clinical study, the German EC approval required the additional statements.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 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 |
|---|---|
|
实验性的：Dipole Density Mapping
|
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 Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events
大体时间：7 days
|
Sites reported all adverse events throughout the study follow-up period regardless of their relationship to the device or procedure.
Each event was classified and adjudicated by the site-specific investigator.
The data were further analyzed by the Sponsor medical reviewer, providing a consistent determination of relationship to device, procedure and the subjects' underlying disease of the atrial arrhythmia condition.
|
7 days
|
|
The Number of Patients for Which Activation Maps Can be Created
大体时间：1 day
|
The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps.
|
1 day
|
合作者和调查者
调查人员
- 首席研究员：Petr Neuzil, MD、Nemocnice na Homolce
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CL-SVT-005
- CL-SVT-002 (其他赠款/资助编号：Acutus Medical)
- CL-SVT-001 (其他标识符：Acutus Medical)
- CL-SVT-004 (其他标识符：Acutus Medical)
- CL-SVT-006 (其他标识符：Acutus Medical)
- CL-SVT-008 (其他标识符：Acutus Medical)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的设备产品
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.