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临床试验/NCT03788941
NCT03788941招募中不适用

The Efficacy and Safety of Left Atrial Appendage Closure in Combination With Catheter Ablation in Patients With Atrial Fibrillation

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,200
试验地点
1
主要终点
Major bleeding

研究概览

简要总结

This study is a prospective cohort study aimed at investigating the efficacy and safety of left atrial appendage closure in combination with catheter ablation in patients with atrial fibrillation.

详细描述

This study is a prospective cohort investigating the efficacy and safety of catheter ablation in combination with left atrial appendage closure in patients with atrial fibrillation.

This study will be conducted in accordance with the following procedures:

  1. Screen out patients in accordance with the inclusion and exclusion criteria. The following assessments should be made: demographic data, medical history, physical examination, vital signs data, the height and body weight, laboratory parameters, ECG examination, assessment for medication and evaluation for inclusion/exclusion criteria.
  2. Participants receive radiofrequency ablation in combination with left atrial appendage closure. Participants will be assessed and observed carefully during and after the operation.
  3. The participants will be followed-up in the third, ninth and twelfth months after the treatments. The main follow-up includes the review of ECG, 24h Holter monitoring, echocardiography, transesophageal echocardiography, coronary CT et al. and AFEQT questionnaire, and brain CT or MRI if necessary. Participants' medication and symptoms will also be observed and recorded. The incidence of stroke, systemic embolism, transient ischemic attack, major bleeding and all-cause death; the rate of patients maintaining sinus rhythm, hospitalization due to heart failure, and perioperative complications such as pericardial tamponade, wound hematoma and long-term surgery-related complications will be recorded. Adverse events during the trial will also be assessed and recorded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • History of paroxysmal/persistent/longstanding persistent atrial fibrillation
  • Refractory to at least one antiarrhythmic drug or unwilling to receive long-term antiarrhythmic drugs;
  • With contraindication of longterm anticoagulation or unwilling to receive longterm anticoagulation
  • CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3
  • Provide informed consent to participate in the study;
  • Between 18-90 years

排除标准

  • myocardial infarction within 3 months
  • Stroke or systemic embolism within 3 months
  • Plan to receive heart transplantation;
  • Life expectancy less than 1 year;
  • Severe bleeding diseases that cannot be treated with short-term anticoagulants;
  • With left atrial or left atrial appendage thrombus;
  • With uncontrolled malignant tumor ;
  • Obvious liver and kidney dysfunction (ALT, AST more than 2 times the upper limit of normal, or CCr <50%);
  • Women who are pregnant, or breastfeeding.
  • Other conditions not suitable to the combined procedure.

结局指标

主要结局

Major bleeding

时间窗: long-term after the procedure.

The incidence of major bleeding in the participants will be reported.

stroke/TIA/systemic embolism

时间窗: long-term after the procedure.

The incidence of stroke/TIA events in the participants will be reported. Participants with clinical manifestations of stroke/TIA will undergo neurological examination and CT scans for diagnosis.

Death

时间窗: long-term after the procedure.

all-cause death

次要结局

  • procedure-related complications(after the procedure.)
  • Heart failure rehospitalization(after the procedure.)
  • maintenance of sinus rhythm(after the procedure outside the 3-month blanking period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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