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NCT Number: NCT07624552

Impact of Atrioventricular Delay Optimization on Ventricular Function in Conduction System Pacing

Conduction system pacing has emerged as a physiological pacing strategy that preserves ventricular electrical activation and minimizes pacing-induced dyssynchrony. However, the optimal atrioventricular delay setting in patients undergoing conduction system pacing remains uncertain.

This study aims to evaluate the effects of individualized echocardiography-guided atrioventricular delay optimization on ventricular function and hemodynamic performance in patients with conduction system pacing. Echocardiographic parameters including global longitudinal strain, left ventricular ejection fraction, left ventricular outflow tract velocity-time integral, cardiac output, and diastolic function indices will be assessed before and after atrioventricular delay optimization.

The study will investigate whether optimization of atrioventricular timing provides additional mechanical and hemodynamic benefits beyond physiological ventricular activation achieved by conduction system pacing alone.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Yıldırım, Turkey (Türkiye)

About this study

Conduction system pacing (CSP), including His bundle pacing and left bundle branch area pacing, has emerged as a physiological pacing strategy capable of preserving ventricular electrical activation and reducing pacing-induced dyssynchrony. Compared with conventional right ventricular pacing, CSP has been associated with improved electrical synchrony, ventricular function, and clinical outcomes.

Despite restoration of physiological ventricular activation, optimal atrioventricular (AV) coupling remains essential for maximizing ventricular filling, stroke volume, and overall cardiac performance. Inadequate AV timing may impair diastolic filling, reduce atrial contribution to ventricular preload, and limit the hemodynamic benefits achieved by physiological pacing. While AV delay optimization has been extensively investigated in cardiac resynchronization therapy, data regarding its role in patients undergoing CSP remain limited.

The present study evaluates the impact of individualized echocardiography-guided AV delay optimization on ventricular mechanical performance and hemodynamic parameters in patients with CSP implanted for atrioventricular block. Comprehensive transthoracic echocardiographic assessment will be performed before and after AV delay optimization. Measurements include left ventricular ejection fraction, global longitudinal strain, left ventricular outflow tract velocity-time integral, cardiac output, chamber dimensions, pulmonary artery systolic pressure, and diastolic function parameters.

The primary objective is to determine the effect of AV delay optimization on global longitudinal strain. Secondary objectives include assessment of changes in left ventricular systolic function, hemodynamic performance, and diastolic parameters. The study aims to provide additional evidence regarding the importance of individualized AV programming in patients undergoing conduction system pacing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 80 years
  • Permanent conduction system pacing implantation for atrioventricular block
  • At least 1 month elapsed since device implantation
  • Sinus rhythm at the time of enrollment
  • Left ventricular ejection fraction >40%
  • Adequate echocardiographic image quality for comprehensive assessment
  • Ability and willingness to provide informed consent

Exclusion criteria

  • Permanent or persistent atrial fibrillation
  • Significant valvular heart disease
  • Active malignancy
  • Severe systemic illness with limited life expectancy
  • Sinus node dysfunction requiring alternative pacing strategies
  • Inadequate echocardiographic image quality
  • Inability to comply with study procedures
  • Refusal to participate in the study

Treatment and study plan

Echocardiography-Guided Atrioventricular Delay Optimization

Device

Atrioventricular delay settings are individually optimized using echocardiographic assessment of transmitral inflow and ventricular filling patterns. Device programming is adjusted to achieve optimal atrioventricular coupling and ventricular performance.

Other names: AV Delay Optimization

Primary outcomes

  1. Global Longitudinal Strain (GLS)

    Time frame: Immediately before and immediately after atrioventricular delay optimization.

    Assessment of left ventricular global longitudinal strain using two-dimensional speckle tracking echocardiography before and after atrioventricular delay optimization.

Secondary outcomes

  1. Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI)

    Time frame: Immediately before and immediately after atrioventricular delay optimization.

    Assessment of forward stroke volume using pulsed-wave Doppler measurements at the left ventricular outflow tract.

  2. Left Ventricular Ejection Fraction (LVEF)

    Time frame: Immediately before and immediately after atrioventricular delay optimization.

    Assessment of left ventricular systolic function using the biplane Simpson method.

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

The Effect Of Atrioventricular Delay Optimization On Ventricular Functions In Patients Undergoing Conduction System Pacing

Acronym: OPTI-CSP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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