NCT01642537已完成不适用
Electroanatomical Mapping of Patients Undergoing Catheter Ablation Procedures Using Rhythmia Mapping System and Catheter
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Major device related adverse cardiac and cerebrovascular events
研究概览
简要总结
The purpose of this study is a feasibility study for the Rhythmia Medical Mapping System and Mapping Catheter on patients undergoing catheter ablation procedures for the treatment of cardiac tachyarrhythmias.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient understands the implications of participating in the study and provides informed consent
- •Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone
- •Patients referred for a catheter ablation procedure to treat an atrial or ventricular arrhythmia
- •Patient can be heparinized during the procedure
排除标准
- •Patients requiring an emergency ablation procedure
- •Patients hemodynamically unstable
- •Patients with NYHA Class III or IV heart failure
- •Women who are pregnant or lactating
- •Patients having cardiac surgery within the past two months
- •Patients with Long QT Syndrome, Brugada Syndrome, or Torsade de Pointes
- •Patients with intracardiac thrombus, tumor, or other abnormality which precludes catheter introduction
- •Patients with acute myocardial infarction within 3 months
- •Patients awaiting cardiac transplantation
- •Patients enrolled in any other clinical study
- •Patients with an age <18 or >75 years
- •Patients with stable/unstable angina or ongoing myocardial ischemia
- •Patients with congenital heart disease (not including atrial septal defect (ASD) or patent foramen ovale (PFO) without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
- •Patients with pulmonary hypertension (mean or systolic pulmonary artery (PA) pressure > 50mm Hg on Doppler echo)
- •Patients with a left atrial diameter > 55 mm
- •Patients with any arrhythmia currently being treated where the arrhythmia or the management may interfere with this study
- •Patients with active infection or sepsis
- •Patients with untreatable allergy to contrast media
- •Patients with a history of blood clotting (bleeding or thrombotic) abnormalities
- •Patients with any known sensitivities to heparin or warfarin
- •Patients with severe chronic obstructive pulmonary disease (COPD) (identified by a forced expiratory volume [FEV1] <1)
- •Patients with severe co morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
结局指标
主要结局
Major device related adverse cardiac and cerebrovascular events
时间窗: 30 days
Device Performance
时间窗: 1 day- Procedure
次要结局
未报告次要终点
研究者
研究点 (1)
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