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Deutsches Device Qualitätsregister

This study has been completed.
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung Identifier:
First received: July 29, 2010
Last updated: June 23, 2016
Last verified: June 2016
It is the aim of this register to document the development of therapies by implantation of Cardioverter/Defibrillators (ICDs) and/or Cardiac Resynchronization therapy (CRT)-Systems.

Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Deutsches Device Qualitätsregister

Resource links provided by NLM:

Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • Characterize consecutive patients with initial implantation of ICD or CRT in hospital daily routine in Germany [ Time Frame: 01/03/2007-12/31/2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Specification of the device and the realization of the implantation as well as the success of the operation [ Time Frame: 01/03/2007-12/31/2011 ] [ Designated as safety issue: No ]
  • Documentation of further interventions needed after the Index Event during hospital stay [ Time Frame: 01/03/2007-12/31/2011 ] [ Designated as safety issue: No ]
  • Documentation of hospital mortality and non-fatal complications [ Time Frame: 01/03/2007-12/31/2011 ] [ Designated as safety issue: No ]
  • Documentation of the 1-year mortality and non-fatal complications [ Time Frame: 01/03/2007-12/31/2011 ] [ Designated as safety issue: No ]
  • Documentation of the dispensary of shocks within one year [ Time Frame: 01/03/2007-12/31/2011 ] [ Designated as safety issue: No ]
  • Documentation of symptomatology and number of hospitalizations [ Time Frame: 01/03/2007-12/31/2011 ] [ Designated as safety issue: No ]
  • Documentation of medication therapy after 12 months [ Time Frame: 01/03/2007-12/31/2011 ] [ Designated as safety issue: No ]

Enrollment: 4008
Study Start Date: March 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Detailed Description:
The possibility of evaluation of successes as well as of the complications of these therapies is needed to make quality management possible. Every German Center, implanting ICDs or CRT-devices, is encouraged to contribute to this register; data are collected by use of an electronical CRF.

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all consecutive patients with an intended implantation of an ICD / CRT.

Inclusion Criteria:

  • The Device register will include all consecutive patients with an intended implantation of an ICD / CRT.

Exclusion Criteria:

  • Missing signed informed consent
  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 identifier: NCT01173783

Vivantes Klinikum Am Urban
Berlin, Germany, 10967
Städtische Kliniken Bielefeld
Bielefeld, Germany, 33526
St. Marien Hospital
Bonn, Germany, 53115
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, Germany, 40217
Asklepios Klinik St Georg
Hamburg, Germany, 20099
St. Vincentius Klinikan AG
Karlsruhe, Germany, 76135
Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Germany, 78050
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Principal Investigator: Jochen Senges, MD Stiftung Institut fuer Herzinfarktforschung
  More Information

Responsible Party: Stiftung Institut fuer Herzinfarktforschung Identifier: NCT01173783     History of Changes
Other Study ID Numbers: DEVICE 
Study First Received: July 29, 2010
Last Updated: June 23, 2016
Health Authority: Germany: German Institute of Medical Documentation and Information
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
Heart failure
Cardiac insufficiency
Implantable Cardioverter/Defibrillator
Cardiac Resynchronization therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on October 21, 2016