Atrioventricular Optimization for Dual Chamber Pacemaker

NCT ID: NCT03556189

Last Updated: 2018-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-12-31

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.

Conditions

AV Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

Case management

Intervention Type: DEVICE

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

Control: Usual care

Usual care is provided with routine pacemaker interrogation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Case management

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yong Seog Oh

OTHER

Sponsor Role: lead

Responsible Party

Yong Seog Oh

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yong-Seog Oh, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

Seoul St Mary's Hospital

Seoul, Seo Ch-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Yong-Seog Oh, MD,PhD

Role: CONTACT

oys@catholic.ac.kr

82-2-2258-6035

Ju Youn Kim, MD

Role: CONTACT

zzoo921@catholic.ac.kr

82-10-5482-7307

Facility Contacts

Ju Youn Kim, MD

Role: primary

zzoo921@catholic.ac.kr

82-10-5482-7307

Other Identifiers

AV delay

Identifier Type: -

Identifier Source: org_study_id