Atrioventricular BlockOPTI-CSPNCT07624552
Impact of Atrioventricular Delay Optimization on Ventricular Function in Conduction System Pacing
A study testing Echocardiography-Guided Atrioventricular Delay Optimization in people with Atrioventricular Block and Conduction System Pacing, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrioventricular Block, Conduction System Pacing
- What is being tested?
- Echocardiography-Guided Atrioventricular Delay Optimization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Oct 2025to 17 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Yıldırım
About this study
Official title: The Effect Of Atrioventricular Delay Optimization On Ventricular Functions In Patients Undergoing 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.
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.
- Conditions
- Atrioventricular Block, Conduction System Pacing
- Being tested
- Echocardiography-Guided Atrioventricular Delay Optimization
- Keywords
- Atrioventicular Block, Atrioventricular Delay Optimization, Conduction System Pacing, Global Longitudinal Strain, Mechanical Resynchronization, Ventricular Function
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography-Guided Atrioventricular Delay OptimizationDevice
Also called AV 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Echocardiography-Guided Atrioventricular Delay Optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Longitudinal Strain (GLS)
Assessment of left ventricular global longitudinal strain using two-dimensional speckle tracking echocardiography before and after atrioventricular delay optimization.
Measured: Immediately before and immediately after atrioventricular delay optimization.
Secondary outcomes (2)
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.
Measured: Immediately before and immediately after atrioventricular delay optimization.
Left Ventricular Ejection Fraction (LVEF)
Assessment of left ventricular systolic function using the biplane Simpson method.
Measured: Immediately before and immediately after atrioventricular delay optimization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start6 Oct 2025
- Primary completion17 Feb 2026
- Study completion17 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrioventricular BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bilal Mete Ülker, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Ahmet Tütüncü, Study chair, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624552
- Sponsor's protocol ID
- BYIEAH-CSP-BMU-2025
- Other IDs
- 2024-TBEK 2025/07-12
- Acronym
- OPTI-CSP
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Atrioventricular Delay Optimization On Ventricular Functions In Patients Undergoing Conduction System Pacing
- ClinicalTrials.gov ID
- NCT07624552
- Acronym / sponsor ID
- OPTI-CSP / BYIEAH-CSP-BMU-2025
- Conditions
- Atrioventricular Block, Conduction System Pacing
- Keywords
- Atrioventicular Block, Atrioventricular Delay Optimization, Conduction System Pacing, Global Longitudinal Strain, Mechanical Resynchronization, Ventricular Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Echocardiography-Guided AV Delay Optimization | Experimental | Device: Echocardiography-Guided Atrioventricular Delay OptimizationParticipants with conduction system pacing undergo individualized echocardiography-guided atrioventricular delay optimization. Echocardiographic and hemodynamic parameters are assessed before and after optimization. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography-Guided Atrioventricular Delay OptimizationAlso: AV Delay OptimizationAtrioventricular 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. | Device | Echocardiography-Guided AV Delay Optimization |
Primary outcome
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.
2 secondary outcomes
Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI)
Time frame: Immediately before and immediately after atrioventricular delay optimization.
Left Ventricular Ejection Fraction (LVEF)
Time frame: Immediately before and immediately after atrioventricular delay optimization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- BackgroundGlikson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Tütüncü study chair
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiography-Guided Atrioventricular Delay Optimization in people with Atrioventricular Block and Conduction System Pacing, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Longitudinal Strain (GLS) (time frame: Immediately before and immediately after atrioventricular delay optimization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07624552, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.