Deutsches Device Qualitätsregister

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Stiftung Institut fuer Herzinfarktforschung.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01173783
First received: July 29, 2010
Last updated: July 30, 2010
Last verified: July 2010
  Purpose

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. 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.


Condition
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 ]

Estimated Enrollment: 8000
Study Start Date: March 2007
  Eligibility

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.

Criteria

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 ClinicalTrials.gov identifier: NCT01173783

Contacts
Contact: Jochen Senges, MD +49 621 503 ext 2801 senges@herzinfarktforschung.de

Locations
Germany
Vivantes Klinikum Am Urban Recruiting
Berlin, Germany, 10967
Contact: Dietrich Andresen, MD         
Städtische Kliniken Bielefeld Recruiting
Bielefeld, Germany, 33526
Contact: Christoph Stellbrink, MD         
St. Marien Hospital Recruiting
Bonn, Germany, 53115
Contact: Th Lewalter, MD         
Evangelisches Krankenhaus Düsseldorf Recruiting
Düsseldorf, Germany, 40217
Contact: Ernst G Vester, MD         
Asklepios Klinik St Georg Recruiting
Hamburg, Germany, 20099
Contact: Karl-Heinz Kuck, MD         
St. Vincentius Klinikan AG Recruiting
Karlsruhe, Germany, 76135
Contact: Gonska, MD         
Klinikum Villingen-Schwenningen Recruiting
Villingen-Schwenningen, Germany, 78050
Contact: Werner Jung, MD         
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Investigators
Principal Investigator: Jochen Senges, MD Stiftung Institut fuer Herzinfarktforschung
  More Information

No publications provided

Responsible Party: Prof Jochen Senges, Institut für Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT01173783     History of Changes
Other Study ID Numbers: DEVICE
Study First Received: July 29, 2010
Last Updated: July 30, 2010
Health Authority: Germany: German Institute of Medical Documentation and Information

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014