NCT01086098

Brief Summary

Limited data exist regarding temporal trends in permanent pacemaker (PPM) implantation. To describe trends in incidence and comorbidities of PPM recipients, the investigators aim to conduct a retrospective population-based cohort study using record linkage, over a 32 year period.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

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

March 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

January 15, 2019

Status Verified

March 1, 2010

Enrollment Period

1 year

First QC Date

March 5, 2010

Last Update Submit

January 11, 2019

Conditions

Pacemakers

Keywords

PacemakersSurvival

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular Mortality

    We will examine time to cardiovascular death from pacemaker implant and relate to the differing indications for pacing

    30 years

Secondary Outcomes (1)

  • Hospitalisation for heart failure

    30 years

Study Arms (1)

All paced patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with pacemakers

You may qualify if:

  • All patients with pacemakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

March 5, 2010

First Posted

March 12, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

January 15, 2019

Record last verified: 2010-03