Perioperative Management of Patients With Pacemakers | NCT03556241

Studies
Perioperative Management of Patients With Pacemakers

NCT03556241

Sponsor

Yong Seog Oh

Status

Unknown status

Last Update Posted

Jun 14, 2018Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Preoperative State
Presence of Pacemaker

Interventions

Case management

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Feb 2019Estimated

Completion Date

Apr 2019Estimated

First Submitted Date

Apr 24, 2017

First Submission Date that Met QC Criteria

Jun 3, 2018

First Posted Date

Jun 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2018

Last Update Posted Date

Jun 14, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yong Seog Oh, professor, Seoul St. Mary's HospitalSponsor-Investigator

Lead Sponsor

Yong Seog OhOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

It has been more than 50 years after pacemaker device is developed. The subjects receiving permanent pacemaker has been increased and the number of patients with pacemaker undergoing surgery has been increased in company. However, in cases using electrocautery during surgery, there is possibility of malfunction of pacemaker due to electromagnetic interference. The factors associated with pacemaker malfunction during surgery have been reported; type of pacemaker, intrinsic heart rate, pacemaker dependency, type of electrocautery, position of generator, distance between generator/lead and electrocautery, duration and power of electrical energy. Conventionally, mode change to VOO before surgery and use of bipolar electrocautery are recommended before surgery but diverse suggestions regarding perioperative pacemaker mode change has been raised. The investigators aimed to contemplate the necessity of perioperative pacemaker mode change by prospective randomized trial. Patients with permanent pacemaker undergoing surgery are randomized into two groups by 1:1 ratio. No mode change is applied before surgery in the case group and VOO mode is applied before surgery in the control group. Exclusion criteria is thoracic surgery, 100% pacemaker dependency and unipolar pacing. The investigators will compare perioperative adverse events. The primary endpoint is asystole and the secondary endpoint is cardiac arrest, pacing inhibition, torsades de pointes and R on T.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Case management	Device	Case management consists keeping patient's current pacemaker mode during surgery	Intervention: No change group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of asystole		Perioperative period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yong-Seog Oh, MD,PhD	Contact	82-2-2258-6035		oys@catholic.ac.kr
Ju Youn Kim, MD	Contact	82-10-5482-7307		zzoo921@catholic.ac.kr

Overall Officials

Name	Affiliation	Role
Yong-Seog Oh, MD,PhD	The Catholic University of Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul St Mary's Hospital	Recruiting	Seoul	Seo Ch-gu	137-701	South Korea