Evaluation of the Acute Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Kardium Inc.
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Acute isolation of all clinically relevant pulmonary veins confirmed by entrance block
研究概览
简要总结
This study will evaluate the safety and acute performance of the Globe® Mapping and Ablation System with the GPS™ Module intended to conduct electroanatomic mapping and ablation treatment of subjects with atrial fibrillation (AF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •≥18 years old and ≤75 years old
- •Symptomatic AF with at least one AF episode electrocardiographically documented within one (1) year prior to enrolment. Documentation may include diagnosis in the patient medical files, electrocardiogram (ECG), Trans-telephonic monitoring (TTM), Holter monitor or telemetry strip.
- •Selected for catheter ablation for the treatment of atrial fibrillation
排除标准
- •History of previous left atrial ablation or surgical treatment for AF/AFL/AT
- •Contraindication for either catheter ablation or epicardial surgery (including, but not limited to: previous thoracic radiation, previous perimyocarditis, previous cardiac tamponade, pleural adhesions, and prior thoracotomy)
- •Presence of LA thrombus by TEE, CT scan, MRI, or angiography
- •Known conditions or anatomical abnormality that may interfere with the device delivery or positioning (e.g. myxoma, tumour, calcification, venous access path narrowing, or tortuosity)
- •Planned concomitant cardiac surgery procedures besides AF treatment (valve, coronary, others)
- •Uncontrolled heart failure or NYHA Class III or IV heart failure
- •Valve repair or replacement or presence of a prosthetic valve
- •Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months
- •MI or PCI procedure within 3 months before screening
- •Left Ventricular Ejection Fraction (LVEF) < 40%
- •Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD)
- •Severe pulmonary hypertension or prior pulmonary stenting
- •History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
- •Contraindication to anticoagulation (e.g., heparin)
- •History of blood clotting or bleeding disease
结局指标
主要结局
Acute isolation of all clinically relevant pulmonary veins confirmed by entrance block
时间窗: start to end of the procedure
Procedure time
时间窗: start to end of the procedure
Incidence of Primary Adverse Events (PAE) occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure
时间窗: start to seven days after the end of the procedure
Fluoroscopy time
时间窗: start to end of the procedure
Fluoroscopy dose area product
时间窗: start to end of the procedure
Catheter dwell time
时间窗: start to end of the procedure
Incidence of all serious adverse events occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure
时间窗: start to seven days after the end of the procedure
次要结局
未报告次要终点