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

• Conditions: Pacemaker; Defibrillators, Implantable

• Registration Number: NCT01138670
• Lead Sponsor: University of Aarhus

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-08
• Last Update Posted: 2012-11-09
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5500

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
complication rate	3 months	any complication that require treatment There is no 'Safety and Tolerability' or 'Pain' measurement.

Trial Locations

Locations (1)

Aarhus Universitetshospital, Skejby; 🇩🇰 Aarhus, Denmark