NCT01038180

Brief Summary

This study examines possible risk factors with regard to complications following pacemaker implantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 1997

Completed
11.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

First QC Date

December 21, 2009

Last Update Submit

December 22, 2009

Conditions

Bradycardia

Keywords

pacemakeradverse effects

Study Arms (1)

pacemaker 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 permanent cardiac pacemaker during the years 1997 to 2008

You may qualify if:

  • permanent cardiac pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • Kirkfeldt RE, Johansen JB, Nohr EA, Moller M, Arnsbo P, Nielsen JC. Risk factors for lead complications in cardiac pacing: a population-based cohort study of 28,860 Danish patients. Heart Rhythm. 2011 Oct;8(10):1622-8. doi: 10.1016/j.hrthm.2011.04.014. Epub 2011 Apr 14.

    PMID: 21699827DERIVED

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rikke E Kirkfeldt, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2009

First Posted

December 23, 2009

Study Start

January 1, 1997

Study Completion

December 1, 2008

Last Updated

December 23, 2009

Record last verified: 2009-12

Locations

DK(1)