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