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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01138670
First received: May 25, 2010
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition
Pacemaker
Defibrillators, Implantable

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Complications Following Pacemaker or ICD Implantation in Denmark

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • complication rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    any complication that require treatment There is no 'Safety and Tolerability' or 'Pain' measurement.


Estimated Enrollment: 5500
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac device group

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All Danish patients receiving a cardiac device (pacemaker, cardiac resynchronization therapy (CRT) or implantable defibrillator cardioverter (ICD)), or undergoing a reoperation from May 2010 to April 2011.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138670

Locations
Denmark
Aarhus Universitetshospital, Skejby
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Rikke E Kirkfeldt, MD Aarhus Universitetshospital, Skejby
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01138670     History of Changes
Other Study ID Numbers: SKS-REK-2
Study First Received: May 25, 2010
Last Updated: November 8, 2012
Health Authority: Denmark: Danish Dataprotection Agency

ClinicalTrials.gov processed this record on May 16, 2013