European Cardiac Resynchronisation Therapy Survey

NCT01185392 | Completed

• 1 other identifier: CRT Survey
• Study Type: observational
• Target: 2,438
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Keywords

Cardiac Resynchronisation Therapy in Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Helse Stavanger HF: lead
• Boston Scientific Corporation: collaborator
• Medtronic: collaborator
• Abbott Medical Devices: collaborator
• Biotronik SE & Co. KG: collaborator
• LivaNova: collaborator
• Roche Diagnostic Ltd.: collaborator

Related Publications (4)

• 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.

  PMID: 19228801 BACKGROUND

• 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.

  PMID: 19723694 RESULT

• 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.

  PMID: 22179034 DERIVED

• 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.

  PMID: 21771823 DERIVED

Related Links

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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Kenneth Dickstein, MD, PHD

  HFA of the ESC

  STUDY CHAIR

• Silvia Priori, MD, PHD

  EHRA of the ESC

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2010
• First Posted: August 19, 2010
• Study Start: November 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: January 1, 2012
• Last Updated: June 27, 2024

Record last verified: 2012-06