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临床试验/NCT03186339
NCT03186339已完成不适用

Validation of the "Toronto Aortic Stenosis Quality of Life Questionnaire" in Patients Undergoing Surgical Aortic Valve Replacement or Transfemoral Transcatheter Aortic Valve Implantation The TASQ Registry

Institut für Pharmakologie und Präventive Medizin10 个研究点 分布在 7 个国家目标入组 272 人开始时间: 2017年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
272
试验地点
10
主要终点
Change in QoL as assessed by SF12 (Short Form 12) Questionnaire

研究概览

简要总结

Prospective, multi-centre, multi-national registry with a follow-up of 3 months, in five European countries and Canada (Toronto), with elective patients undergoing TF-TAVI (n=120) and isolated SAVR (n=120), respectively and a control group of 50 patients receiving medical treatment only. All patient groups will fill in three different questionnaires to assess quality of life in 5 different languages (English, French, German, Italian and Spanish). One of these will be a new questionnaire, the Toronto Aortic Stenosis QoL (Quality of Life) questionnaire (TASQ).

详细描述

Currently, there are two cardiovascular disease QoL scales which have been used in studies of patients with aortic stenosis - the Minnesota Living with Heart Failure (MLHF) questionnaire and the Kansas City Cardiomyopathy Questionnaire (KCCQ).

The KCCQ has now become the only cited health related (HR) QoL validated scale for use among a growing TAVI (Transcatheter Aortic Valve Implantation) patient population; however questions on the KCCQ do not reflect the concerns and lifestyle of patients proceeding for aortic valve intervention. Many of the questions do not reflect this patient population's perspective of well-being in contrast to perceptions by the general cardiac population on which it was validated. It is important to capture the disruptions caused by a chronic disease and its treatment on lifestyles, activities, and interests; that is interference with psychologically meaningful activity. It has been noted that this interference varies by disease process and treatment by general scales such as the Illness Intrusiveness Scale .

Due to issues of limited validity of the KCCQ for TAVI / SAVR (Surgical Aortic Valve Replacement) patients related to symptom items not being revised from their original use for congestive heart failure, a new original HR-QoL questionnaire was proposed: The "Toronto Aortic Stenosis Quality of Life Questionnaire" (TASQ) is a health specific measurement tool designed to measure changes in quality of life in aortic stenosis patients. The aim of this study is to validate this questionnaire in this specific patient population.

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

  • severe aortic stenosis
  • age > 18 years
  • in case of TAVI or SAVR: intention to treat the AS employing an Edwards valve

排除标准

  • patients not providing informed consent
  • patients with major cognitive impairment
  • emergency patients

结局指标

主要结局

Change in QoL as assessed by SF12 (Short Form 12) Questionnaire

时间窗: 3 months from baseline examination

Change in quality of life as assessed by the SF12 using a points system

Change in QoL as assessed by KCCQ (The Kansas City Cardiomyopathy Questionnaire)

时间窗: 3 months from baseline examination

Change in quality of life as assessed by the KCCQ using a points system

Change in QoL as assessed by TASQ (Toronto Aortic Stenosis Quality of Life Questionnaire)

时间窗: 3 months from baseline examination

Change in quality of life as assessed by the TASQ using a points system

次要结局

  • Difference in change in QoL between arms(3 months from baseline examination)

研究者

发起方
Institut für Pharmakologie und Präventive Medizin
申办方类型
Network
责任方
Sponsor

研究点 (10)

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