NCT01173783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,008

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 24, 2016

Status Verified

June 1, 2016

Enrollment Period

4.4 years

First QC Date

July 29, 2010

Last Update Submit

June 23, 2016

Conditions

Heart Failure

Keywords

Heart failureCardiac insufficiencyImplantable Cardioverter/DefibrillatorCardiac Resynchronization therapyICDCRTRegister

Outcome Measures

Primary Outcomes (1)

  • Characterize consecutive patients with initial implantation of ICD or CRT in hospital daily routine in Germany

    01/03/2007-12/31/2011

Secondary Outcomes (7)

  • 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 hospital mortality and non-fatal complications

    01/03/2007-12/31/2011

  • Documentation of the 1-year 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

  • +2 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Missing signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Vivantes Klinikum Am Urban

Berlin, 10967, Germany

Location

Städtische Kliniken Bielefeld

Bielefeld, 33526, Germany

Location

St. Marien Hospital

Bonn, 53115, Germany

Location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, 40217, Germany

Location

Asklepios Klinik St Georg

Hamburg, 20099, Germany

Location

St. Vincentius Klinikan AG

Karlsruhe, 76135, Germany

Location

Klinikum Villingen-Schwenningen

Villingen-Schwenningen, 78050, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jochen Senges, MD

    Stiftung Institut fuer Herzinfarktforschung

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2010

First Posted

August 2, 2010

Study Start

March 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

June 24, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(7)