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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by University of Aarhus.
Recruitment status was  Active, not recruiting
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
  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 ] [ 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

Ages Eligible for Study:   Child, Adult, Senior
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 September 23, 2016