European Cardiac Resynchronisation Therapy Survey
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Purpose
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.
| Condition |
|---|
|
Heart Failure |
| Study Type: | Observational |
| 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.
| Enrollment: | 2438 |
| 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- eligible patients for CRT-P or CRT-D.
Exclusion Criteria:
- none
Contacts and Locations| 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 |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nigussie Bogale, MD, PhD, FESC, Helse Stavanger HF |
| ClinicalTrials.gov Identifier: | NCT01185392 History of Changes |
| Other Study ID Numbers: | CRT Survey |
| Study First Received: | August 7, 2010 |
| Last Updated: | June 7, 2012 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Helse Stavanger HF:
|
Cardiac Resynchronisation Therapy in Heart Failure |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013