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临床试验/NCT03987945
NCT03987945Unknown不适用

Prognostic Implications of Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation at Shanghai Tenth People's Hospital

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Major adverse cardiovascular and cerebral events (MACCE)

研究概览

简要总结

The prognostic implication of left atrial appendage occlusion (LAAO) procedure in non-valvular atrial fibrillation (NVAF) patients from China is still unclear. We aim to investigate the impact of LAAO procedure on subsequent clinical outcomes in patients from China.

详细描述

Although the left atrial appendage occlusion (LAAO) procedure has increasingly been performed to prevent the occurrence of ischemic stroke events among patients with non-valvular atrial fibrillation (NVAF), the clinical benefits and prognostic implications of which have not been well characterized in patients from China. As a result, we aim to conduct an observational study to explore the prognostic impact of LAAO in patient with NVAF who are hospitalized in Shanghai Tenth People's Hospital.

研究设计

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

入排标准

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

入选标准

  • Patients who were admitted for NVAF undergoing LAAO procedure between January 2014 and December 2017 in the Cardiology Department of Shanghai Tenth People's Hospital;
  • Adult patients (>18 years old).

排除标准

  • Patients with rheumatic valvular disease;
  • Patients with sick sinus syndrome;
  • Patients who had a history of cardiac surgery (i.e., CABG);
  • patients who had received the catheter radiofrequency ablation procedure.

结局指标

主要结局

Major adverse cardiovascular and cerebral events (MACCE)

时间窗: From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years

A composite of all-cause death, ischemic stroke, heart failure rehospitalization and major bleeding events

次要结局

  • Ischemic stroke(From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years)
  • Cardiovascular death(From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years)
  • Major bleeding(From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years)
  • All-cause death(From the time of performing LAAO procedure until occurrence of death, lose to follow up or Jan, 2020, maximum up to 6 years)
  • Heart failure rehospitalization(From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years)
  • Pericardial effusion(From the time of performing LAAO procedure until occurrence of an outcome of interest, death, lose to follow up or Jan, 2020, maximum up to 6 years)

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ya-Wei Xu

Chief Physician

Shanghai 10th People's Hospital

研究点 (1)

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