NCT03556241

Brief Summary

Traditionally, when a patient who received permanent pacemaker undergoes surgery, physicians change pacemaker mode to DDD and recommend to use bipolar electrocautery to minimize electromagnetic interference. However, pacemaker function is improving and there's diverse suggestions for such situations. The investigators aimed to contemplate the necessity of perioperative pacemaker mode change. Patients with permanent pacemaker undergoing surgery are randomized into two groups by 1:1 ratio. No mode change is applied before surgery in case group and VOO is applied before surgery in control group. Perioperative adverse event would be compared in both groups.

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

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

March 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2017

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

3.9 years

First QC Date

April 24, 2017

Last Update Submit

June 3, 2018

Conditions

Preoperative StatePresence of Pacemaker

Outcome Measures

Primary Outcomes (1)

  • Occurrence of asystole

    Perioperative period

Study Arms (2)

Intervention: No change group

EXPERIMENTAL

Case management consists keeping patient's current pacemaker mode during surgery

Device: Case management

Control: Mode change group

NO INTERVENTION

Usual care consists changing pacemaker mode to VOO before surgery

Interventions

Case managementDEVICE

Case management consists keeping patient's current pacemaker mode during surgery

Intervention: No change group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 19 years old Patients undergoing surgery using electrocautery who received permanent pacemaker

You may not qualify if:

  • Thoracic surgery (lung, esophagus, heart, breast) Totally pacemaker dependent patient. Unipolar pacing

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

Study Officials

  • Yong-Seog Oh, MD,PhD

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong-Seog Oh, MD,PhD

CONTACT

82-2-2258-6035oys@catholic.ac.kr

Ju Youn Kim, MD

CONTACT

82-10-5482-7307zzoo921@catholic.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 24, 2017

First Posted

June 14, 2018

Study Start

March 1, 2015

Primary Completion

February 1, 2019

Study Completion

April 1, 2019

Last Updated

June 14, 2018

Record last verified: 2018-06

Locations

KR(1)