Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 8
- 主要终点
- The Number of Patients for Which Activation Maps Can be Created
研究概览
简要总结
Use of dipole density mapping to identify activation in complex supraventricular tachycardias.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Dipole Density Mapping
干预措施: Dipole Density Mapping with AcQMap followed by ablation (Device)
结局指标
主要结局
The Number of Patients for Which Activation Maps Can be Created
时间窗: 1 day
The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps.
Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events
时间窗: 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.
次要结局
未报告次要终点