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Completed

NCT Number: NCT01173783

Deutsches Device Qualitätsregister

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Vivantes Klinikum Am Urban, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Missing signed informed consent

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Documentation of further interventions needed after the Index Event during hospital stay

    Time frame: 01/03/2007-12/31/2011

  3. Documentation of hospital mortality and non-fatal complications

    Time frame: 01/03/2007-12/31/2011

  4. Documentation of the 1-year mortality and non-fatal complications

    Time frame: 01/03/2007-12/31/2011

  5. Documentation of the dispensary of shocks within one year

    Time frame: 01/03/2007-12/31/2011

  6. Documentation of symptomatology and number of hospitalizations

    Time frame: 01/03/2007-12/31/2011

  7. Documentation of medication therapy after 12 months

    Time frame: 01/03/2007-12/31/2011

Sponsors and collaborators

Lead sponsor

Stiftung Institut fuer Herzinfarktforschung

Other

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Aug 2, 2010
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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