跳至主要内容
临床试验/NCT01594814
NCT01594814已完成不适用

Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT - a Quality of Life, Utility and Willingness to Pay Study (PPRA Study)

National Institute of Cardiology, Warsaw, Poland1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
1
主要终点
Health-related quality of life (HRQOL)

研究概览

简要总结

Atrioventricular nodal reciprocating tachycardia (AVNRT) and atrioventricular reciprocating tachycardia (AVRT) are two similar supraventricular re-entry tachycardias (SVT) emerging in relatively young age in patients without apparent structural heart disease or significant comorbidities. The treatment of choice in those patients is radiofrequency ablation (RFA).

The PPRA study is a prospective observational study developed to thoroughly analyze quality of life, utility and willingness-to-pay of Polish patients undergoing RF ablation of AVNRT or AVRT.

Based on collected data the investigators will prepare a profile of patient who will benefit most from radiofrequency ablation and who should be scheduled in first place for the ablation in case of problems with accessibility to this service.

What is more an analysis of medical and indirect costs of care will be performed.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent
  • Age above 18
  • Scheduled RFA due to AVNRT or AVRT
  • Sufficient knowledge of the Polish language to independently complete the questionnaires

排除标准

  • No written informed consent
  • Health states significantly impairing QoL (eg. stroke, advanced heart failure)

结局指标

主要结局

Health-related quality of life (HRQOL)

时间窗: two months

Mean score of Patient Perception of Arrhythmia Questionnaire (PPAQ) - a disease-specific QoL questionnaire for patients suffering from supraventricular tachycardia translated and validated according to ISPOR (International Society For Pharmacoeconomics and Outcomes Research) guidelines

次要结局

  • Effectiveness(two days)
  • Utility of health state(two months)
  • Medical and indirect cost(one year)
  • Willingness-to-pay(one day)

研究者

发起方
National Institute of Cardiology, Warsaw, Poland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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