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Deutsches Device Qualitätsregister

Deutsches Device Qualitätsregister

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01173783
Enrollment
4008
Registered
2010-08-02
Start date
2007-03-31
Completion date
2011-08-31
Last updated
2016-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, Cardiac insufficiency, Implantable Cardioverter/Defibrillator, Cardiac Resynchronization therapy, ICD, CRT, Register

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.

Interventions

None listed

Sponsors

Stiftung Institut fuer Herzinfarktforschung
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
Characterize consecutive patients with initial implantation of ICD or CRT in hospital daily routine in Germany01/03/2007-12/31/2011

Secondary

MeasureTime frame
Documentation of further interventions needed after the Index Event during hospital stay01/03/2007-12/31/2011
Documentation of hospital mortality and non-fatal complications01/03/2007-12/31/2011
Documentation of the 1-year mortality and non-fatal complications01/03/2007-12/31/2011
Specification of the device and the realization of the implantation as well as the success of the operation01/03/2007-12/31/2011
Documentation of symptomatology and number of hospitalizations01/03/2007-12/31/2011
Documentation of medication therapy after 12 months01/03/2007-12/31/2011
Documentation of the dispensary of shocks within one year01/03/2007-12/31/2011

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026