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Deutsches Device Qualitätsregister

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01173783
First Posted: August 2, 2010
Last Update Posted: June 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung
  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.

Condition
Heart Failure

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

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 ]

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 ]
  • Documentation of further interventions needed after the Index Event during hospital stay [ Time Frame: 01/03/2007-12/31/2011 ]
  • Documentation of hospital mortality and non-fatal complications [ Time Frame: 01/03/2007-12/31/2011 ]
  • Documentation of the 1-year mortality and non-fatal complications [ Time Frame: 01/03/2007-12/31/2011 ]
  • Documentation of the dispensary of shocks within one year [ Time Frame: 01/03/2007-12/31/2011 ]
  • Documentation of symptomatology and number of hospitalizations [ Time Frame: 01/03/2007-12/31/2011 ]
  • Documentation of medication therapy after 12 months [ Time Frame: 01/03/2007-12/31/2011 ]

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173783


Locations
Germany
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
Investigators
Principal Investigator: Jochen Senges, MD Stiftung Institut fuer Herzinfarktforschung
  More Information

Responsible Party: Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT01173783     History of Changes
Other Study ID Numbers: DEVICE
First Submitted: July 29, 2010
First Posted: August 2, 2010
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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