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OpenTrials
Completed

NCT Number: NCT01185392

European Cardiac Resynchronisation Therapy Survey

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • Abbott Medical Devices
  • Biotronik SE & Co. KG
  • Boston Scientific Corporation
  • LivaNova
  • Medtronic
  • Roche Diagnostic Ltd.

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2012
First posted
Aug 19, 2010
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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