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Atrioventricular Optimization for Dual Chamber Pacemaker

Effect of Atrioventricular Optimization on Left Ventricular Function With Dual Chamber Pacemaker; Prospective Randomized Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03556189
Enrollment
70
Registered
2018-06-14
Start date
2015-09-30
Completion date
2019-12-31
Last updated
2018-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AV Block

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.

Interventions

DEVICECase management

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

Sponsors

Yong Seog Oh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Left ventricular ejection fractionone year after randomization

Secondary

MeasureTime frame
Left ventricular end-systolic diameterone year after randomization
cardiac outputone year after randomization
Left ventricular end-diastolic diameterone year after randomization
6-minute walking testone year after randomization
NYHA classone year after randomization
BNPone year after randomization

Countries

South Korea

Contacts

Primary ContactYong-Seog Oh, MD,PhD
oys@catholic.ac.kr82-2-2258-6035
Backup ContactJu Youn Kim, MD
zzoo921@catholic.ac.kr82-10-5482-7307

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026