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临床试验/NCT02306460
NCT02306460终止不适用

Frontal Cognitive Control Functions Before and After Percutaneous Catheter Procedures in Treatment of Atrial Fibrillation

Tampere University Hospital1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2015年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
17
试验地点
1
主要终点
Changes in response speeds (ms) and response error rate (%) in the executive RT-test

研究概览

简要总结

Atrial fibrillation is a common arrythmia. It is an independent risk factor for stroke. There for anticoagulation therapy is used for atrial fibrillation patients. Alternatively, left atrial appendix closure can be used, if the risk for bleeding complications is deemed greater than the possible antithrombotic benefit of anticoagulation medication. Up to 70% of ischemic complications can be prevented with anticoagulation therapy, and left atrial appendix closure seems to have comparable results. Also left atrial catherter ablation (LACA) is gaining popularity as a therapeutic intervention for atrial fibrillation.

However, the procedure is associated with 0,5-1% perioperative risk of clinically evident transient ischemic attack (TIA) or stroke. While the incidence of clinically evident ischemic complications remain relatively low, recent data suggest that 13%-20% of patients undergoing LACA are affected by post-operative neurocognitive dysfunction (POCD) 90 days after ablation.

The goal of the study is to improve detection of subtle brain dysfunction after cardiac interventions by employing an experimental executive reaction time (RT) test along with EEG recording in aims to improve objective detection of subtle brain dysfunction assumed to underlie persistent cognitive, somatic, and affective complaints reported by patients who have undergone atrial fibrillation ablation.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 50-70
  • undergoing left atrial catheter ablation or percutaneous left atrial appendix closure procedure
  • In the ablation group, patients will qualify for the study if they have symptomatic atrial fibrillation (EHRA classification 2-4) and if their risk of thromboembolic complications with CHA2DS2VASc scale is low (0-2 points).

排除标准

  • Age under 18 or over 70 years.
  • Contraindication for anticoagulation therapy (in ablation group),
  • Previous neurological or psychiatric disorder.
  • Significant visual problem that can't be corrected for,
  • problems with upper arm/hand use, that would make the execution of the test difficult.
  • normal contraindications for the ablation and appendix closure procedures.

结局指标

主要结局

Changes in response speeds (ms) and response error rate (%) in the executive RT-test

时间窗: 1 day before procedure, 3 months and 1 year after post-procedure

次要结局

  • Changes in amplitude of N2/P3 complex in the EEG recording(1 day before procedure, 3 months and 1 year after post-procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kati Järvelä

MD, PhD

Tampere University Hospital

研究点 (1)

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