Clinical trial NCT01185392: European Cardiac Resynchronisation Therapy Survey
Official title: European Cardiac Resynchronisation Therapy Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Cardiac Resynchronisation Therapy in Heart Failure
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Boston Scientific Corporation
name: Medtronic
name: Abbott Medical Devices
name: Biotronik SE & Co. KG
name: LivaNova
name: Roche Diagnostic Ltd.
First posted: 2010-08-19
Enrollment: 2438
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: 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.
timeFrame: November 2008-October 2010
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: HFA of the ESC
name: Kenneth Dickstein, MD, PHD
role: STUDY_CHAIR
affiliation: EHRA of the ESC
name: Silvia Priori, MD, PHD
role: STUDY_CHAIR
affiliation: EHRA of the ESC
name: Angelo Auricchio, MD, PHD
role: STUDY_DIRECTOR
affiliation: EHRA of the ESC
name: Josep Brugada, MD, PHD
role: STUDY_DIRECTOR
affiliation: HFA of the ESC
name: John Cleland, MD, PHD
role: STUDY_DIRECTOR
affiliation: EAE of the ESC
name: Geneviève Derumeaux, MD, PHD
role: STUDY_DIRECTOR
affiliation: EHRA of the ESC
name: Daniel Gras, MD, PHD
role: STUDY_DIRECTOR
affiliation: HFA of the ESC
name: Michel Komajda, MD, PHD
role: STUDY_DIRECTOR
affiliation: EHRA of the ESC
name: Cecilia Linde, MD, PHD
role: STUDY_DIRECTOR
affiliation: EHRA of the ESC
name: John Morgan, MD, PHD
role: STUDY_DIRECTOR
affiliation: HFA of the ESC
name: Dirk J van Veldhuisen, MD, PHD
role: STUDY_DIRECTOR
affiliation: The Institut für Herzinfarktforschung in Ludwigshafen, Germany
name: Anselm Gitt, MD
role: STUDY_DIRECTOR
affiliation: Stavanger University Hospital and University of Bergen, Norway
name: Nigussie Bogale, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.