Deutsches Device Qualitätsregister

June 23, 2016 updated by: Stiftung Institut fuer Herzinfarktforschung
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

4008

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10967
        • Vivantes Klinikum Am Urban
      • Bielefeld, Germany, 33526
        • Städtische Kliniken Bielefeld
      • Bonn, Germany, 53115
        • St. Marien Hospital
      • Düsseldorf, Germany, 40217
        • Evangelisches Krankenhaus Düsseldorf
      • Hamburg, Germany, 20099
        • Asklepios Klinik St Georg
      • Karlsruhe, Germany, 76135
        • St. Vincentius Klinikan AG
      • Villingen-Schwenningen, Germany, 78050
        • Klinikum Villingen-Schwenningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all consecutive patients with an intended implantation of an ICD / CRT.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Missing signed informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Characterize consecutive patients with initial implantation of ICD or CRT in hospital daily routine in Germany
Time Frame: 01/03/2007-12/31/2011
01/03/2007-12/31/2011

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
01/03/2007-12/31/2011
Documentation of hospital mortality and non-fatal complications
Time Frame: 01/03/2007-12/31/2011
01/03/2007-12/31/2011
Documentation of the 1-year mortality and non-fatal complications
Time Frame: 01/03/2007-12/31/2011
01/03/2007-12/31/2011
Documentation of the dispensary of shocks within one year
Time Frame: 01/03/2007-12/31/2011
01/03/2007-12/31/2011
Documentation of symptomatology and number of hospitalizations
Time Frame: 01/03/2007-12/31/2011
01/03/2007-12/31/2011
Documentation of medication therapy after 12 months
Time Frame: 01/03/2007-12/31/2011
01/03/2007-12/31/2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stiftung Institut fuer Herzinfarktforschung

Investigators

  • Principal Investigator: Jochen Senges, MD, Stiftung Institut fuer Herzinfarktforschung

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 29, 2010

First Submitted That Met QC Criteria

July 30, 2010

First Posted (Estimate)

August 2, 2010

Study Record Updates

Last Update Posted (Estimate)

June 24, 2016

Last Update Submitted That Met QC Criteria

June 23, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEVICE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe