Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Physician rating of the electroanatomic map created by the NeuTrace System via a questionnaire
研究概览
简要总结
The trial is a prospective, non-randomized, single-arm feasibility trial to evaluate physician acceptance of the NeuTrace System v1.0 for cardiac electroanatomic mapping.
详细描述
Arrhythmias, or abnormal heart rhythms, are a major cause of morbidity and mortality worldwide. In patients with arrhythmias, electrophysiology (EP) studies are often performed to assess the electrical system of the heart. Since its introduction in the 1990s, electroanatomic mapping has become a cornerstone of EP studies. Electroanatomic mapping systems allow for non-fluoroscopic navigation of the heart and the creation of three-dimensional (3D) anatomic and electroanatomic maps. These maps facilitate diagnosing and treating arrhythmias.
The NeuTrace System is a cardiac EP mapping system that is intended to be used during catheter-based atrial and ventricular mapping procedures. The system is designed to acquire and analyze data points and use this information to display 3D anatomical and electroanatomic mapping of the human heart. The system is used with a compatible, marketed magnetic sensor-enabled catheter and compatible EP recording system to acquire the location information and local electrogram needed to create the cardiac maps. The purpose of the trial is to evaluate physician acceptance and feasibility of the NeuTrace System v1.0 for cardiac electroanatomic mapping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with standard indications for an electrophysiology study and/or catheter ablation per European Heart Rhythm Association/Heart Rhythm Society) guidelines and/or judgement of the investigator
- •Age 18 to 80
- •Signed Informed Consent Form
排除标准
- •Any cardiac surgery, myocardial infarction, percutaneous coronary intervention/percutaneous transluminal coronary angioplasty, or coronary artery stenting which occurred during the 90-day interval preceding the date that participant signed the Informed Consent Form
- •Unstable angina
- •NHYA class III or IV congestive heart failure and/or known left ventricular ejection fraction less than 45%
- •Thrombocytosis, thrombocytopenia
- •Contraindication to anticoagulation therapy
- •Active systemic infection
- •Cryoglobulinemia
- •Known reversible causes of arrhythmia
- •Any cerebral ischemic event (stroke or transient ischemic attacks) which occurred during the 180-day interval preceding the date the participant signed the Informed Consent Form, or any known unresolved complications from the previous stroke/transient ischemic attack
- •Pregnancy
- •Unwilling or unable to comply fully with study procedures
结局指标
主要结局
Physician rating of the electroanatomic map created by the NeuTrace System via a questionnaire
时间窗: Immediately post-procedure
At the completion of each electrophysiology study, the principal investigator will be asked to complete a questionnaire in which he or she qualitatively rates the electroanatomic map created by the NeuTrace System on a numeric scale from 1 to 5 (1 = not satisfied, 5 = very satisfied).
次要结局
- Physician rating of catheter visibility during electroanatomic mapping with NeuTrace System via a questionnaire(Immediately post-procedure)
- Physician rating of the manual annotation of ablation points with the NeuTrace System via a questionnaire(Immediately post-procedure)
- Physician rating of the accuracy of the anatomical map created with the NeuTrace System compared to an image obtained via computerized tomography, magnetic resonance imaging, or intracardiac echocardiography via a questionnaire(Immediately post-procedure)
- Measurement of the shift in the electroanatomic during the procedure with the NeuTrace System(Immediately post-procedure)
- Number of participants with serious adverse events at 30-day post-procedure telephone follow up(30 days post-procedure)
- Measurement of the drift in the electroanatomic during the procedure with the NeuTrace System(Immediately post-procedure)
- Physician rating of the total mapping time with the NeuTrace System via a questionnaire(Immediately post-procedure)