ClinicalTrials.gg
CompletedNCT07624552OPTI-CSPUpdated Jun 8, 2026

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

An interventional study of Echocardiography-Guided Atrioventricular Delay Optimization in Atrioventricular Block and Conduction System Pacing, sponsored by Bursa Yuksek Ihtisas Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Bursa Yuksek Ihtisas Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Oct 2025, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the detailed description

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.

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Conditions studied

  • Atrioventricular Block
  • Conduction System Pacing

Keywords

  • Atrioventicular Block
  • Atrioventricular Delay Optimization
  • Conduction System Pacing
  • Global Longitudinal Strain
  • Mechanical Resynchronization
  • Ventricular Function
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In context

Atrioventricular Block

117 studies on the registry are indexed under Atrioventricular Block; 43 are open to participants now.

This study's enrollment of 39 is below the median of 127 across 78 interventional studies indexed under Atrioventricular Block.

Browse Atrioventricular Block studies →

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital is the lead sponsor of 52 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • >40%
  • Adequate echocardiographic image quality for comprehensive assessment
  • Ability and willingness to provide

Exclusion criteria

Exclusion Criteria:

  • Permanent or persistent atrial fibrillation
  • Significant valvular heart disease
  • Active
  • Severe systemic illness with limited
  • Sinus node dysfunction requiring alternative pacing strategies
  • Inadequate echocardiographic image quality
  • Inability to comply with study procedures
  • Refusal to participate in the study
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Echocardiography-Guided AV Delay Optimization

    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

  • DeviceEchocardiography-Guided Atrioventricular Delay Optimization

    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

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What researchers measure

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.

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

Secondary outcomes

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

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

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

  2. Left Ventricular Ejection Fraction (LVEF)

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

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

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Study locations

1 site
  • University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
    Bursa, Yıldırım, Turkey (Türkiye)
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References and documents

Publications

  • 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.

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2025 to primary completion in Feb 2026, 4 months.

Of 44 interventional studies with no phase under Atrioventricular Block, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 29, 2026
First posted
Jun 3, 2026
StartActual
Oct 6, 2025
Primary completionActual
Feb 17, 2026
CompletionActual
Feb 17, 2026
Last update
Jun 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07624552
Lead sponsor
Bursa Yuksek Ihtisas Training and Research Hospital
Responsible party
Bilal Mete Ülker (Cardiology Resident, Bursa Yuksek Ihtisas Training and Research Hospital) — Principal investigator
First posted
Jun 3, 2026
Start date
Oct 6, 2025
Primary completion
Feb 17, 2026
Completion
Feb 17, 2026
Last update
Jun 8, 2026

Study contacts

Ahmet Tütüncü
study chair · Bursa Yuksek Ihtisas Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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