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Impact of Right Ventricular Pacing Determined by Electrocardiography (RVpacing)

Primary Purpose

Atrioventricular Block

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Septal pacing
Apex pacing
Sponsored by
Yong Seog Oh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrioventricular Block focused on measuring atrioventricular block, cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Atrioventricular block, pacemaker scheduled

Exclusion Criteria:

  • 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)

Sites / Locations

  • Seoul st. mary's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Septal pacing group

Apex pacing group

Arm Description

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

Put RV lead around the apex

Outcomes

Primary Outcome Measures

> 10% decrease of ejection fraction

Secondary Outcome Measures

Full Information

First Posted
July 4, 2013
Last Updated
September 10, 2018
Sponsor
Yong Seog Oh
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1. Study Identification

Unique Protocol Identification Number
NCT01922518
Brief Title
Impact of Right Ventricular Pacing Determined by Electrocardiography
Acronym
RVpacing
Official Title
Impact of Right Ventricular Pacing Determined by Electrocardiography; Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yong Seog Oh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients who has Atrioventricular block scheduled for artificial pacemaker Randomized select 1:1 apex beats and ventricular septal beat.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrioventricular Block
Keywords
atrioventricular block, cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Septal pacing group
Arm Type
Active Comparator
Arm Description
Put RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis
Arm Title
Apex pacing group
Arm Type
Active Comparator
Arm Description
Put RV lead around the apex
Intervention Type
Procedure
Intervention Name(s)
Septal pacing
Intervention Description
Put RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis
Intervention Type
Procedure
Intervention Name(s)
Apex pacing
Intervention Description
Put RV lead around the apex
Primary Outcome Measure Information:
Title
> 10% decrease of ejection fraction
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Atrioventricular block, pacemaker scheduled Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Seog Oh, MD
Phone
82-10-71013810
Email
oys@chatholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong seog Oh, MD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul st. mary's hospital
City
Seoul
State/Province
Seo Cho Gu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Seog Oh, MD
Phone
82-10-71013810
Email
oys@chatholic.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25380704
Citation
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.
Results Reference
derived

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Impact of Right Ventricular Pacing Determined by Electrocardiography

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