NCT01922518

Brief Summary

Typically pacemaker electrode has been attached to the right ventricular apex. This method lead to Non-physiological Ventricular contraction. It has been reported to cause by ventricular dysfunction. In conclusion, this study demonstrate that impact of right ventricular pacing determined by electrocardiography was planned.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
233

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

6.3 years

First QC Date

July 4, 2013

Last Update Submit

April 21, 2024

Conditions

Atrioventricular Block

Keywords

atrioventricular block, cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • > 10% decrease of ejection fraction

    3 years

Study Arms (2)

Septal pacing group

ACTIVE COMPARATOR

Put RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis

Procedure: Septal pacing

Apex pacing group

ACTIVE COMPARATOR

Put RV lead around the apex

Procedure: Apex pacing

Interventions

Septal pacingPROCEDURE

Put RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis

Septal pacing group
Apex pacingPROCEDURE

Put RV lead around the apex

Apex pacing group

Eligibility Criteria

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

You may qualify if:

  • Atrioventricular block, pacemaker scheduled

You may not qualify if:

  • History of myocardial infarction
  • Valvular heart disease (grade ≥ 2 )
  • History of Left ventricular dysfunction ( ejection fraction \<50% or LV dimension \>60 mm in the pre-procedure echocardiogram)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul st. mary's hospital

Seoul, Seo Cho Gu, South Korea

Location

Related Publications (1)

  • Kim SH, Oh YS, Nam GB, Choi KJ, Park JS, Park SW, Park SJ, On YK, Kim JS, Shin WS, Kim JH, Jang SW, Lee MY, Kim YH, Rho TH. Paced QRS axis as a predictor of pacing-induced left ventricular dysfunction. J Interv Card Electrophysiol. 2014 Dec;41(3):223-9. doi: 10.1007/s10840-014-9950-7. Epub 2014 Nov 8.

    PMID: 25380704DERIVED

MeSH Terms

Conditions

Atrioventricular BlockCardiomyopathies

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yong seog Oh, MD

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

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
professor

Study Record Dates

First Submitted

July 4, 2013

First Posted

August 14, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)