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Clinical Trials/NCT01173783
NCT01173783CompletedNot Applicable

Deutsches Device Qualitätsregister

Stiftung Institut fuer Herzinfarktforschung7 sites in 1 country4,008 target enrollmentStarted: March 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
4,008
Locations
7
Primary Endpoint
Characterize consecutive patients with initial implantation of ICD or CRT in hospital daily routine in Germany
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •Missing signed informed consent

Outcomes

Primary Outcomes

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

  • Specification of the device and the realization of the implantation as well as the success of the operation(01/03/2007-12/31/2011)
  • Documentation of further interventions needed after the Index Event during hospital stay(01/03/2007-12/31/2011)
  • Documentation of medication therapy after 12 months(01/03/2007-12/31/2011)
  • Documentation of hospital mortality and non-fatal complications(01/03/2007-12/31/2011)
  • Documentation of the dispensary of shocks within one year(01/03/2007-12/31/2011)
  • Documentation of the 1-year mortality and non-fatal complications(01/03/2007-12/31/2011)
  • Documentation of symptomatology and number of hospitalizations(01/03/2007-12/31/2011)

Investigators

Sponsor
Stiftung Institut fuer Herzinfarktforschung
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (7)

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Deutsches Device Qualitätsregister | Clinical Trial