European Cardiac Resynchronisation Therapy Survey
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||European Cardiac Resynchronisation Therapy Survey|
- 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 ] [ Designated as safety issue: No ]
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.
|Study Start Date:||November 2008|
|Study Completion Date:||January 2012|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185392
|Study Chair:||Kenneth Dickstein, MD, PHD||HFA of the ESC|
|Study Chair:||Silvia Priori, MD, PHD||EHRA of the ESC|
|Study Director:||Angelo Auricchio, MD, PHD||EHRA of the ESC|
|Study Director:||Josep Brugada, MD, PHD||EHRA of the ESC|
|Study Director:||John Cleland, MD, PHD||HFA of the ESC|
|Study Director:||Geneviève Derumeaux, MD, PHD||EAE of the ESC|
|Study Director:||Daniel Gras, MD, PHD||EHRA of the ESC|
|Study Director:||Michel Komajda, MD, PHD||HFA of the ESC|
|Study Director:||Cecilia Linde, MD, PHD||EHRA of the ESC|
|Study Director:||John Morgan, MD, PHD||EHRA of the ESC|
|Study Director:||Dirk J van Veldhuisen, MD, PHD||HFA of the ESC|
|Study Director:||Anselm Gitt, MD||The Institut für Herzinfarktforschung in Ludwigshafen, Germany|
|Study Director:||Nigussie Bogale, MD||Stavanger University Hospital and University of Bergen, Norway|