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NCT01138670 Clinical Trial

Complications Following Pacemaker or Implantable Defibrillator Cardioverter (ICD) Implantation in Denmark

Pacemaker Clinical Trial

Official title:
Complications Following Pacemaker or ICD Implantation in Denmark

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01138670
Other study ID # SKS-REK-2
Secondary ID
Status Active, not recruiting
Phase N/A
First received May 25, 2010
Last updated November 8, 2012
Start date May 2010
Est. completion date December 2014

Study information
Verified date November 2012
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

This study examines possible risk factors with regard to complications following pacemaker or implantable defibrillator cardioverter (ICD) implantation.

Description:

This study examines possible risk factors with regard to complications following pacemaker or implantable defibrillator cardioverter (ICD)implantation. Furthermore validation af the Danish Pacemaker and ICD Register will be conducted.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 5500
Est. completion date December 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- patients receiving a cardiac device (pacemaker, cardiac resynchronization therapy (CRT) or implantable defibrillator cardioverter (ICD)), or undergoing a reoperation

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Aarhus Universitetshospital, Skejby Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary complication rate any complication that require treatment There is no 'Safety and Tolerability' or 'Pain' measurement. 3 months No
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