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临床试验/NCT04833985
NCT04833985已完成不适用

Intracardiac Versus Transesophageal Echocardiography Versus Fluoroscopy Only Guidance for Combined Catheter Ablation for Atrial Fibrillation and Left Atrial Appendage Occlusion.

xieruiqin1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年7月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
fluoroscopy time were recorded

研究概览

简要总结

A total of 75 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion combined with radiofrequency ablation, which were divided into 3 groups. The operation was performed under the guidance of intracardiac echocardiography and transesophageal echocardiography and fluoroscope only respectively (allocation ratio 1:1:1). During the operation, the total amount of contrast medium injected, the fluoroscopy time and the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients. All patients underwent transesophageal echocardiography before and 3 months after operation, and the results were explained by two experienced ultrasound doctors to measure the presence of left atrial thrombus, residual shunt and device-related thrombus. All patients were examined by transthoracic echocardiography 3 months after operation to evaluate new pericardial effusion, pericardial tamponade, instrument embolization / displacement and so on. The baseline clinical and surgical features and hospitalization outcomes of patients guided by ICE and TEE and fluoroscopy only were recorded and compared. Clinical endpoints include death, new pericardial effusion that does not require pericardiocentesis, tamponade with pericardiocentesis, instrument embolism / displacement, bleeding at the entry site, thromboembolic events (stroke / transient ischemic attack [TIA]). The purpose of this study was to evaluate the feasibility, safety and effectiveness of intracardiac echocardiographic (ICE)-guided and transesophageal echocardiographic (TEE)-guided and fluoroscopy only-guided left atrial appendage occlusion combined with radiofrequency ablation. The average follow-up time is 3 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • •AF attack occurred in patients with a duration of more than one year, patients taking class I and class III antiarrhythmic drugs could not prevent AF, patients younger than 80 years old Cha2ds2-vasc score ≥2 and HAS-BLED score ≥3, not suitable for long-term oral anticoagulant drugs.

排除标准

  • •Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation), patients undergoing prosthetic heart valve replacement, pregnant women, patients with previous liver and kidney diseases, malignant tumors or blood system diseases.

研究组 & 干预措施

fluoroscopy only guidance

Experimental

干预措施: LAAC combined with radiofrequency ablation (Procedure)

transesophageal echocardiography guidance

Experimental

干预措施: LAAC combined with radiofrequency ablation (Procedure)

intracardiac echocardiography guidance

Experimental

干预措施: LAAC combined with radiofrequency ablation (Procedure)

结局指标

主要结局

fluoroscopy time were recorded

时间窗: in the procedure

mGy

injected contrast media

时间窗: in the procedure

milliliter

次要结局

  • the size of the selected umbrella in operation(in the procedure)
  • residual shunt and DRT after transcatheter closure of left atrial appendage detected(before operation and 3 months after operation)
  • the time from femoral vein puncture to transseptal puncture to closure were recorded(in the procedure)
  • The size of the LAA(in the procedure)
  • pericardial tamponade were detected(3 months after operation)
  • new pericardial effusion were detected(3 months after operation)

研究者

发起方
xieruiqin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

xieruiqin

director of cardiology department

The Second Hospital of Hebei Medical University

研究点 (1)

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