European Cardiac Resynchronisation Therapy Survey

This study has been completed.
Sponsor:
Collaborators:
Boston Scientific Corporation
Medtronic
St. Jude Medical
Biotronik SE & Co. KG
Sorin Group
Roche Diagnostic Ltd.
Information provided by (Responsible Party):
Nigussie Bogale, Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01185392
First received: August 7, 2010
Last updated: June 7, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • 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)
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185392

Sponsors and Collaborators
Helse Stavanger HF
Boston Scientific Corporation
Medtronic
St. Jude Medical
Biotronik SE & Co. KG
Sorin Group
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
  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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014