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临床试验/NCT01185392
NCT01185392已完成不适用

European Cardiac Resynchronisation Therapy Survey

Helse Stavanger HF0 个研究点目标入组 2,438 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,438
主要终点
To describe current European CRT implantation practice and there is a need to precisely quantify the extent of treatment failures, adverse experience and complications associated with implantation.

研究概览

简要总结

The European CRT survey represents a joint initiative between two ESC associations; the Heart Failure Association and the European Heart Rhythm Association. The survey will be performed in collaboration with The Institute für Herzinfarktforschung in Ludwigshafen which will handle the data collection and data analysis.

详细描述

This European CRT Survey was initiated by the Heart Failure Association (HFA) and the European Heart Rhythm Association (EHRA) of the ESC in order to describe current European practice and routines associated with CRT-P/CRT-D implantations based on sample of patients enrolled in 13 countries. The data collected following implantation provides information including clinical characteristics, diagnostic criteria, implantation routines and techniques, adverse experience, and assessment of adherence to guideline recommendations. The single follow-up visit at 1 year (9-15 months) will provide information regarding short-term clinical outcomes.

The primary objective of this Survey is to describe current European practice based on a broad sampling in 13 countries. The information collected will enable practice between centres and countries to be compared and permit benchmarking with national and international practice. The survey provides valuable quality assurance assessment for individual centres, permits limited economic analyses and broadly evaluates adherence to guideline recommendations.

The following 13 European countries contributed patients to the survey: Austria, Belgium, France, Germany, Ireland, Israel, Italy, the Netherlands, Norway, Spain, Sweden, Switzerland and UK. Two national coordinators, one each from the fields of heart failure and electrophysiology, were selected and given the responsibility to facilitate recruitment in their respective countries.

Follow the link for complete list of the members of the Scientific Committee and national coordinators.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • eligible patients for CRT-P or CRT-D.

排除标准

  • 未提供

结局指标

主要结局

To describe current European CRT implantation practice and there is a need to precisely quantify the extent of treatment failures, adverse experience and complications associated with implantation.

时间窗: November 2008-October 2010

The Survey will capture data from patients receiving CRT-P/CRT-D devises: * Demographics and clinical characteristics * Diagnostic criteria assessed prior to implantation * Pharmacological therapy at baseline and follow-up * Implantation procedure and techniques * Device programming * Short and long-term outcomes * Adverse experience and hospitalisation * Economic analyses * Adherence to guidelines These data should also provide information contrasting practice between centres and countries and adherence to guideline recommendations.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

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