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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by University of Aarhus.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01138670
First Posted: June 7, 2010
Last Update Posted: November 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Aarhus
  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:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • complication rate [ Time Frame: 3 months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01138670     History of Changes
Other Study ID Numbers: SKS-REK-2
First Submitted: May 25, 2010
First Posted: June 7, 2010
Last Update Posted: November 9, 2012
Last Verified: November 2012