NCT02217046

Brief Summary

Cardiovascular implantable electronic device (CIED) infections have been increasing out of proportion to the number of devices implanted the investigators investigated recent trends and possible causes of the increasing numbers of Cardiovascular implantable electronic device infections.

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
352

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

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

December 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

11.7 years

First QC Date

August 12, 2014

Last Update Submit

April 4, 2019

Conditions

Infection

Keywords

Infectionpreventioncardiac devices

Outcome Measures

Primary Outcomes (1)

  • freedom of cardiac device-related infection

    check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG

    1 year after precedure

Secondary Outcomes (1)

  • freedom of endocarditis

    1 year after precedure

Other Outcomes (1)

  • freedom of general infection

    1 year after procedure

Study Arms (2)

device replacement

EXPERIMENTAL

remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze

Procedure: device replacement(pocket capsule removal)

control group

NO INTERVENTION

remove previously inserted cardiac device and the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze

Interventions

device replacement(pocket capsule removal)PROCEDURE

remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze

device replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled for cardiac devices replacement

You may not qualify if:

  • under the age of 18
  • take an antibiotic
  • history of infection within 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St Mary's Hospital

Seoul, Seo Ch-gu, 137-701, South Korea

RECRUITING

MeSH Terms

Conditions

Infections

Study Officials

  • Yong Seog Oh, Ph.D

    Seoul St. Mary's Hospital

    STUDY CHAIR

Central Study Contacts

Yong Seog Oh, Ph.D

CONTACT

82-10-7101-3810oys@catholic.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 15, 2014

Study Start

December 1, 2013

Primary Completion

August 1, 2025

Study Completion

October 1, 2025

Last Updated

April 5, 2019

Record last verified: 2019-04

Locations

KR(1)