NCT01138670

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 9, 2012

Status Verified

November 1, 2012

Enrollment Period

3.6 years

First QC Date

May 25, 2010

Last Update Submit

November 8, 2012

Conditions

PacemakerDefibrillators, Implantable

Outcome Measures

Primary Outcomes (1)

  • complication rate

    any complication that require treatment There is no 'Safety and Tolerability' or 'Pain' measurement.

    3 months

Study Arms (1)

Cardiac device group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus Universitetshospital, Skejby

Aarhus, 8200, Denmark

Location

Study Officials

  • Rikke E Kirkfeldt, MD

    Aarhus Universitetshospital, Skejby

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2010

First Posted

June 7, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

November 9, 2012

Record last verified: 2012-11

Locations

DK(1)