Impact of Atrioventricular Delay Optimization on Ventricular Function in Conduction System Pacing (OPTI-CSP)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Yıldırım
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Bursa, Yıldırım, 터키 (Türkiye)
- University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Global Longitudinal Strain (GLS)
기간: Immediately before and immediately after atrioventricular delay optimization.
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Assessment of left ventricular global longitudinal strain using two-dimensional speckle tracking echocardiography before and after atrioventricular delay optimization.
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Immediately before and immediately after atrioventricular delay optimization.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI)
기간: Immediately before and immediately after atrioventricular delay optimization.
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Assessment of forward stroke volume using pulsed-wave Doppler measurements at the left ventricular outflow tract.
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Immediately before and immediately after atrioventricular delay optimization.
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Left Ventricular Ejection Fraction (LVEF)
기간: Immediately before and immediately after atrioventricular delay optimization.
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Assessment of left ventricular systolic function using the biplane Simpson method.
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Immediately before and immediately after atrioventricular delay optimization.
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공동 작업자 및 조사자
수사관
- 연구 의자: Ahmet Tütüncü, Bursa Yuksek Ihtisas Training and Research Hospital
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- BYIEAH-CSP-BMU-2025
- 2024-TBEK 2025/07-12 (기타 식별자: SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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