European Cardiac Resynchronisation Therapy Survey

Completed

• Conditions: Heart Failure

• Registration Number: NCT01185392
• Lead Sponsor: Helse Stavanger HF

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-06
• Study First Submitted: 2010-08-07
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Study Completion: 2012-01
• Status Verified: 2012-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2438

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.