Impact of Right Ventricular Pacing Determined by Electrocardiography (RVpacing)

April 21, 2024 updated by: Yong Seog Oh

Impact of Right Ventricular Pacing Determined by Electrocardiography; Prospective Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

233

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seo Cho Gu
      • Seoul, Seo Cho Gu, Korea, Republic of
        • Seoul St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Septal pacing group
Put RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis
Procedure: Septal pacing
Put RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis
Active Comparator: Apex pacing group
Put RV lead around the apex
Procedure: Apex pacing
Put RV lead around the apex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
> 10% decrease of ejection fraction
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yong Seog Oh

Investigators

  • Principal Investigator: Yong Seog Oh, MD, Seoul St. Mary's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

August 11, 2013

First Posted (Estimated)

August 14, 2013

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 21, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SeoulStMary-RVP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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