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.

Study Overview

• Status: Completed
• Conditions: Heart Failure

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 Type: Observational
• Enrollment (Actual): 2438

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients successfully implanted with a new CRT-P, CRT-D or upgrades during the inclusion period were eligible. The successful procedure itself identified the patient as a survey candidate. Patients screened but not successfully implanted were not entered into the survey. Ethics approval and written informed consent were obtained in countries where required.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	November 2008-October 2010

Collaborators and Investigators

• Sponsor: Helse Stavanger HF
• Collaborators: Boston Scientific Corporation; Medtronic; Abbott Medical Devices; Biotronik SE & Co. KG; LivaNova; Roche Diagnostic Ltd.
• Investigators: 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

Publications and helpful links

General Publications

• CRT Survey Scientific Committee. European cardiac resynchronization therapy survey: rationale and design. Eur J Heart Fail. 2009 Mar;11(3):326-30. doi: 10.1093/eurjhf/hfp030.
• Dickstein K, Bogale N, Priori S, Auricchio A, Cleland JG, Gitt A, Limbourg T, Linde C, van Veldhuisen DJ, Brugada J; Scientific Committee; National Coordinators. The European cardiac resynchronization therapy survey. Eur Heart J. 2009 Oct;30(20):2450-60. doi: 10.1093/eurheartj/ehp359. Epub 2009 Aug 31.
• Bogale N, Priori S, Cleland JG, Brugada J, Linde C, Auricchio A, van Veldhuisen DJ, Limbourg T, Gitt A, Gras D, Stellbrink C, Gasparini M, Metra M, Derumeaux G, Gadler F, Buga L, Dickstein K; Scientific Committee, National Coordinators, and Investigators. The European CRT Survey: 1 year (9-15 months) follow-up results. Eur J Heart Fail. 2012 Jan;14(1):61-73. doi: 10.1093/eurjhf/hfr158.
• Bogale N, Witte K, Priori S, Cleland J, Auricchio A, Gadler F, Gitt A, Limbourg T, Linde C, Dickstein K; Scientific Committee, National coordinators and the investigators. The European Cardiac Resynchronization Therapy Survey: comparison of outcomes between de novo cardiac resynchronization therapy implantations and upgrades. Eur J Heart Fail. 2011 Sep;13(9):974-83. doi: 10.1093/eurjhf/hfr085. Epub 2011 Jul 19.

Helpful Links

• Synopsis of the Survey, list of participating countries and members of the Scientific Committee and national coordinators

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: August 7, 2010
• First Submitted That Met QC Criteria: August 18, 2010
• First Posted (Estimate): August 19, 2010

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Cardiac Resynchronisation Therapy in Heart Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CRT Survey