Atrioventricular Optimization for Dual Chamber Pacemaker

NCT03556189 | Unknown

• 1 other identifier: AV delay
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

AV Block

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction

  one year after randomization

Secondary Outcomes (6)

• Left ventricular end-diastolic diameter

  one year after randomization

• Left ventricular end-systolic diameter

  one year after randomization

• cardiac output

  one year after randomization

• BNP

  one year after randomization

• 6-minute walking test

  one year after randomization

Study Arms (2)

Experimental

EXPERIMENTAL

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

Device: Case management

Control: Usual care

NO INTERVENTION

Usual care is provided with routine pacemaker interrogation.

Interventions

Case management DEVICE

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

Experimental

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yong Seog Oh: lead

Study Sites (1)

Seoul St Mary's Hospital

Seoul, Seo Ch-gu, 137-701, South Korea

RECRUITING

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yong-Seog Oh, MD,PhD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong-Seog Oh, MD,PhD

CONTACT

82-2-2258-6035; oys@catholic.ac.kr

Ju Youn Kim, MD

CONTACT

82-10-5482-7307; zzoo921@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: June 14, 2018
• Study Start: September 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

KR (1)