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

NCT07624552 | Completed

• 2 other identifiers: BYIEAH-CSP-BMU-20252024-TBEK 2025/07-12
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrioventricular Block; Conduction System Pacing

Keywords

Atrioventicular Block; Atrioventricular Delay Optimization; Conduction System Pacing; Global Longitudinal Strain; Mechanical Resynchronization; Ventricular Function

Outcome Measures

Primary Outcomes (1)

• Global Longitudinal Strain (GLS)

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

  Immediately before and immediately after atrioventricular delay optimization.

Secondary Outcomes (2)

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

  Immediately before and immediately after atrioventricular delay optimization.

• Left Ventricular Ejection Fraction (LVEF)

  Immediately before and immediately after atrioventricular delay optimization.

Study Arms (1)

Echocardiography-Guided AV Delay Optimization

EXPERIMENTAL

Participants with conduction system pacing undergo individualized echocardiography-guided atrioventricular delay optimization. Echocardiographic and hemodynamic parameters are assessed before and after optimization.

Device: Echocardiography-Guided Atrioventricular Delay Optimization

Interventions

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.

Also known as: AV Delay Optimization

Echocardiography-Guided AV Delay Optimization

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Yıldırım, Turkey (Türkiye)

Location

Related Publications (1)

• Glikson et al. ESC Clinical Consensus Statement on Conduction System Pacing Glikson M, Vijayaraman P, Ellenbogen KA, et al. European Society of Cardiology (ESC) clinical consensus statement on indications for conduction system pacing. Europace. 2025;27(4):euaf050. Coluccia et al. Optimization of the Atrioventricular Delay in Conduction System Pacing Coluccia G, Padeletti L, Della Bella P, et al. Optimization of the atrioventricular delay in conduction system pacing. J Cardiovasc Electrophysiol. 2023;34(6):1441-1451. Pujol-López et al. LEVEL-AT Trial Secondary Findings Pujol-López M, et al. Longitudinal comparison of dyssynchrony correction and strain improvement by conduction system pacing: LEVEL-AT trial secondary findings. Eur Heart J Cardiovasc Imaging. 2024;25(10):1394-1404. Hua et al. Comparison of Left Bundle Branch and His Bundle Pacing Hua W, Fan X, Niu H, et al. Comparison of left bundle branch and His bundle pacing in bradycardia patients. JACC Clin Electrophysiol. 2020;6(10):1291-1299. Sweeney et al. Adverse Effect of Ventricular Pacing Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration. Circulation. 2003;107(23):2932-2937.

  BACKGROUND

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

• Ahmet Tütüncü

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Resident

Model Details: This is a prospective, single-center, single-group interventional study. All enrolled participants with conduction system pacing undergo individualized echocardiography-guided atrioventricular delay optimization. Ventricular function and hemodynamic parameters are evaluated before and after optimization using transthoracic echocardiography. Each participant serves as his or her own control for outcome assessment.

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 3, 2026
• Study Start: October 6, 2025
• Primary Completion: February 17, 2026
• Study Completion: February 17, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)