NCT02016950

Brief Summary

Investigators seek to observe the long term patterns of arrhythmias detected by permanent pacemakers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,551

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 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

First Submitted

Initial submission to the registry

December 11, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

8 months

First QC Date

December 11, 2013

Last Update Submit

February 10, 2015

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation burden

    Proportion of monitored time in atrial fibrillation

    28 days to 1 year

Secondary Outcomes (1)

  • Atrial fibrillation episode frequency

    28 days to 1 year

Study Arms (1)

Permanent pacemaker

Pre-existing permanent pacemakers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those with permanent pacemakers

You may qualify if:

  • Pre-existing dual chamber permanent pacemaker

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastbourne General Hospital

Eastbourne, E Sussex, BN21 2UD, United Kingdom

Location

Related Publications (1)

  • Sugihara C, Veasey R, Freemantle N, Podd S, Furniss S, Sulke N. The development of AF over time in patients with permanent pacemakers: objective assessment with pacemaker diagnostics demonstrates distinct patterns of AF. Europace. 2015 Jun;17(6):864-70. doi: 10.1093/europace/euv032.

    PMID: 26023175DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Neil Sulke, MD

    Eastbourne General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Cardiologist

Study Record Dates

First Submitted

December 11, 2013

First Posted

December 20, 2013

Study Start

June 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 12, 2015

Record last verified: 2015-02

Locations

GB(1)