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Atrioventricular Optimization for Dual Chamber Pacemaker

Primary Purpose

AV Block

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

About this trial

This is an interventional treatment trial for AV Block

Eligibility Criteria

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

Inclusion Criteria:

  • Received or scheduled to receive permanent pacemaker due to AV block

Exclusion Criteria:

  • Left ventricular ejection fraction <50% or Left ventricular end-diastolic diameter>60mm Significant valvular disease (≥mild)

Sites / Locations

  • Seoul St Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control: Usual care

Arm Description

case management consists adjusting AV delay of pacemaker to achieve best cardiac output measured by trans-thoracic echocardiogram

Usual care is provided with routine pacemaker interrogation.

Outcomes

Primary Outcome Measures

Left ventricular ejection fraction

Secondary Outcome Measures

Left ventricular end-diastolic diameter
Left ventricular end-systolic diameter
cardiac output
BNP
6-minute walking test
NYHA class

Full Information

First Posted
April 24, 2017
Last Updated
June 3, 2018
Sponsor
Yong Seog Oh
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1. Study Identification

Unique Protocol Identification Number
NCT03556189
Brief Title
Atrioventricular Optimization for Dual Chamber Pacemaker
Official Title
Effect of Atrioventricular Optimization on Left Ventricular Function With Dual Chamber Pacemaker; Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 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
This study aims to examine the effect of atrioventricular synchrony in AV block patients who received permanent pacemaker. By achieving physiologic ventricular diastolic filling, adjustment of atrioventricular delay of pacemaker might affect the long term outcome of left ventricular function and remodelling. The investigators designed to randomize AV block patients who already have or anticipated to receive pacemaker, into two groups. Patients in intervention group undergo reprogramming AV delay of pacemaker to the best value to increase cardiac output measured by transthoracic echocardiogram and the patients in control group undergo routinely scheduled pacemaker programming. The primary endpoint is improvement of LV systolic function and the secondary endpoint is change in left ventricular volume, cardiac output, BNP, 6-minute walk capacity and NYHA class after one year.
Detailed Description
It is well-known that persistent right ventricular apical pacing induces left ventricular dysfunction. The most important risk factor is the ratio of ventricular pacing so the effort to reduce pacing ratio is needed. However, almost 100% ventricular pacing is inevitable in complete atrio-ventricular block patients with implanted pacemaker. Traditionally the ventricular lead of the pacemaker is positioned in right ventricular apex and previous literatures reported that such right ventricular apical pacing impedes physiological ventricular contraction and induces left ventricular contractile dysfunction in long-term. The alternative positions of ventricular lead are right ventricular outflow tract and ventricular septum but the benefits are not yet clearly prooved. Additionally, adjusting atrio-ventricular delay is reportedto affect cardiac output by altering diastolic filling. The investigators aimed to analyze the effect of AV dealy in long-term left ventricular contractile function. Patients over 19 years old who received or anticipated to receive permanent pacemaker due to AV block are randomized to 1:1 ratio into two groups. Patients in intervention group undergo reprogramming AV delay of pacemaker to the best value to increase cardiac output measured by transthoracic echocardiogram and the patients in control group undergo routinely scheduled pacemaker programming. Patients with underlying LV systolic dysfunction or significant valvular heart disease are excluded. Six-minute walk test, BNP, transthoracic echocardiogram, NYHA class are examined at baseline and after one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AV Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
case management consists adjusting AV delay of pacemaker to achieve best cardiac output measured by trans-thoracic echocardiogram
Arm Title
Control: Usual care
Arm Type
No Intervention
Arm Description
Usual care is provided with routine pacemaker interrogation.
Intervention Type
Device
Intervention Name(s)
Case management
Intervention Description
Case management consists adjusting AV delay of pacemaker to achieve best cardiac output measured by trans-thoracic echocardiogram
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction
Time Frame
one year after randomization
Secondary Outcome Measure Information:
Title
Left ventricular end-diastolic diameter
Time Frame
one year after randomization
Title
Left ventricular end-systolic diameter
Time Frame
one year after randomization
Title
cardiac output
Time Frame
one year after randomization
Title
BNP
Time Frame
one year after randomization
Title
6-minute walking test
Time Frame
one year after randomization
Title
NYHA class
Time Frame
one year after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Received or scheduled to receive permanent pacemaker due to AV block Exclusion Criteria: Left ventricular ejection fraction <50% or Left ventricular end-diastolic diameter>60mm Significant valvular disease (≥mild)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong-Seog Oh, MD,PhD
Phone
82-2-2258-6035
Email
oys@catholic.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ju Youn Kim, MD
Phone
82-10-5482-7307
Email
zzoo921@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-Seog Oh, MD,PhD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St Mary's Hospital
City
Seoul
State/Province
Seo Ch-gu
ZIP/Postal Code
137-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ju Youn Kim, MD
Phone
82-10-5482-7307
Email
zzoo921@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Yong Seog Oh, Ph.D

12. IPD Sharing Statement

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Atrioventricular Optimization for Dual Chamber Pacemaker

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