Grid eXplore Mapping Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Rate of specified device and/or procedure-related serious adverse events
研究概览
简要总结
The purpose of the trial is to find out if the Grid X Mapping Catheter and EnSite X EP System with EnSite X Software v3.1.1, the devices that are being studied, are safe and effective in treating Chinese patients who have atrial fibrillation.
Participants will receive a procedure called catheter mapping and ablation to treat their abnormal heart rhythms and are required to complete 4 follow-up visits at 7 days, 3 months, 6 months and 12 months after the procedure for checkups and tests.
详细描述
This is a prospective, non-randomized, multicenter, pre-National Medical Products Administration (NMPA) approval study to confirm the safety and effectiveness of the Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ when used with EnSite™ X EP System v3.1.1 to create accurate geometries and voltage maps in the atria.
A total of up to 200 subjects who have paroxysmal atrial fibrillation will be enrolled in this clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Subject must provide written informed consent prior to any clinical investigation-related procedure.
- •Subject is at least 18 years of age.
- •Documented symptomatic paroxysmal AF, defined as:
- •Physician's note indicating self-terminating AF AND
- •Electrocardiographically documented AF NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.
- •Subject plans to undergo a cardiac electroanatomic mapping and ablation procedure to treat their paroxysmal AF.
- •Able and willing to comply with all trial requirements including pre-procedure, post-procedure, and follow-up testing and requirements
排除标准
- •Primary diagnosis or indication for treatment of persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
- •Known presence of cardiac thrombus.
- •Known existing circumferential pericardial effusion >2 mm prior to catheter insertion.
- •Presence of any condition that precludes appropriate vascular access
- •Implanted intracardiac device within 30 days prior to the procedure
- •Pregnant or nursing
- •Patients who have had a ventriculotomy or atriotomy within 28 days prior to the procedure
- •Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
- •Stroke or TIA (transient ischemic attack) within the last 90 days
- •History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
- •Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
- •Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
- •Previous left atrial surgical procedure (including left atrial appendage (LAA) closure device)
- •Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
- •Previous tricuspid or mitral valve replacement or repair
- •Patients with prosthetic valves
- •Patients with a myxoma
- •Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
- •Stent, constriction, or stenosis in a pulmonary vein
- •Rheumatic heart disease
- •Hypertrophic cardiomyopathy
- •Active systemic infection
- •Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- •Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from this study Sponsor
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
- •Individuals without legal authority
- •Individuals unable to read or write
研究组 & 干预措施
Grid X and EnSite X v3.1.1 Software
干预措施: Grid X and EnSite X v3.1.1 Software (Device)
结局指标
主要结局
Rate of specified device and/or procedure-related serious adverse events
时间窗: From the study procedure to subject's discharge from the hospital
Safety will be summarized as the rate of subjects experiencing a device and/or procedure-related serious adverse event with onset prior to subject discharge from the hospital after any study procedure that used the Grid X mapping catheter and EnSite X EP System (v3.1.1), as defined below: * Esophageal perforating complications * Cardiac tamponade/perforation * Death * Heart block * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in diaphragmatic paralysis * Pulmonary edema * Pulmonary vein stenosis * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Major vascular access complications / major bleeding event * Device and/or procedure related cardiovascular and/or pulmonary adverse event that prolongs hospitalization for more than 48 hours (excluding hospitalization solely for arrhythmia recurrence or non-urgent cardioversion)
Proportion of subjects with ablation targets identified by HD Grid X catheter
时间窗: During the study procedure
The primary effectiveness endpoint will be defined as the proportion of subjects in which ablation targets were able to be defined or identified by HD mapping using the Grid X catheter. The definitions of ablation targets include, but are not limited to: * Reconnected pulmonary veins * Low voltage zones * Slow conduction sites * Focal arrhythmias * Complex fractionated electrograms * Areas of fibrosis/scar
次要结局
未报告次要终点