REstoration of SYNChronous Cardiac Function Due to Physiologic cArdiac Pacing Modalities With Clinical Endpoints RESYNC-PACE
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Composite of All-Cause Mortality and Heart Failure Hospitalization
研究概览
简要总结
The goal of this observational study is to evaluate the long-term clinical outcomes of physiologic cardiac resynchronization therapy (CRT) using conduction system pacing strategies compared with conventional biventricular CRT in patients with heart failure with reduced ejection fraction (HFrEF) and electrical dyssynchrony.
The main questions it aims to answer are:
- Does physiologic CRT (including left bundle branch area pacing [LBBAP] and LBBAP-optimized CRT) reduce the combined risk of all-cause mortality and heart failure hospitalization compared with conventional biventricular CRT?
- Does physiologic CRT improve cardiac function and reverse ventricular remodeling more effectively than conventional CRT?
Participants receiving physiologic CRT as part of routine clinical care will undergo standard follow-up evaluations, including electrocardiography, echocardiography, laboratory testing, and device interrogation. Clinical outcomes will be collected prospectively for 24 months and compared with a historical cohort of patients treated with conventional biventricular CRT.
The study will assess clinical outcomes, echocardiographic response, electrical resynchronization parameters, and device-related safety in a real-world heart failure population.
详细描述
Background
Heart failure with reduced ejection fraction (HFrEF) is associated with substantial morbidity, mortality, and healthcare utilization despite continuous advances in guideline-directed medical therapy. Cardiac resynchronization therapy (CRT) has become an established treatment for patients with symptomatic HFrEF and electrical dyssynchrony. Conventional biventricular pacing improves ventricular synchrony and clinical outcomes; however, approximately one-third of treated patients do not achieve a satisfactory response.
Conduction system pacing (CSP), particularly left bundle branch area pacing (LBBAP), has emerged as a physiological pacing strategy capable of directly engaging the native His-Purkinje conduction system. Compared with conventional biventricular pacing, CSP may produce more physiological ventricular activation, narrower paced QRS complexes, improved electrical synchrony, and greater reverse ventricular remodeling. Nevertheless, evidence regarding its long-term effectiveness in routine clinical practice remains limited, particularly in heterogeneous populations with different conduction abnormalities.
Study Rationale
The RESYNC-PACE study was designed to evaluate the effectiveness of individualized physiologic cardiac resynchronization strategies in a real-world population of patients with HFrEF requiring CRT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Symptomatic heart failure despite guideline-directed medical therapy.
- •Left ventricular ejection fraction (LVEF) ≤40%.
- •Indication for cardiac resynchronization therapy according to contemporary ESC guideline recommendations.
- •QRS duration ≥150 ms with either:
- •Left bundle branch block (LBBB), or Intraventricular conduction delay (IVCD).
- •Planned implantation of a CRT system
- •Ability to provide written informed consent
- •Expected survival greater than 24 months.
排除标准
- •Age <18 years and Age 100 < years
- •Pregnancy or breastfeeding.
- •Inability or unwillingness to provide informed consent.
- •Life expectancy <12 months due to non-cardiac comorbidities.
- •Active systemic infection or infection involving a cardiac implantable electronic device.
- •Reversible causes of heart failure expected to improve without CRT.
- •Participation in another interventional clinical trial that may affect study outcomes.
- •Inability to comply with follow-up requirements.
- •Missing essential baseline or follow-up data (retrospective cohort).
- •Any condition that, in the opinion of the investigators, would make participation inappropriate or interfere with study assessments.
研究组 & 干预措施
Left bundle branch block patients
LBBB Cohort (qLV-guided Cardiac Resynchronization Therapy)
Patients in this cohort have symptomatic heart failure with reduced left ventricular ejection fraction and complete left bundle branch block (LBBB) according to contemporary guideline criteria. Cardiac resynchronization therapy is performed using a personalized implantation strategy guided by the qLV ratio, defined as the interval between QRS onset and local left ventricular activation divided by the intrinsic QRS duration. The left ventricular lead is positioned at the site with the longest achievable electrical delay to maximize resynchronization benefit. Patients receive either conventional biventricular CRT or LOT- CRT according to clinical decision-making and anatomical feasibility. The cohort is followed longitudinally to evaluate the relationship between qLV-guided lead placement, electrical resynchronization, reverse ventricular remodeling, heart failure hospitalization, and all-cause mortality.
干预措施: Physiologic cardiac resynchronization using conduction system pacing and selective LV lead optimization. (Device)
Intraventricular conduction delay patients
IVCD Cohort (Conduction System Pacing-Guided Resynchronization Strategy)
Patients in this cohort have symptomatic heart failure with reduced left ventricular ejection fraction and intraventricular conduction delay (IVCD) without typical left bundle branch block morphology. The resynchronization strategy is guided by the degree of electrical correction achieved with conduction system pacing. During implantation, left bundle branch area pacing (LBBAP) is attempted and paced QRS duration is assessed. If conduction system pacing alone results in a paced QRS duration greater than 130 ms, a Left Bundle Branch Area Pacing Optimized Cardiac Resynchronization Therapy (LOT-CRT) system is implanted by adding a left ventricular lead to further improve ventricular synchrony. The cohort is followed longitudinally to evaluate the association between electrical resynchronization, reverse ventricular remodeling, heart failure hospitalization, and all-cause mortality.
干预措施: Physiologic cardiac resynchronization using conduction system pacing and selective LV lead optimization. (Device)
结局指标
主要结局
Composite of All-Cause Mortality and Heart Failure Hospitalization
时间窗: 24 months
Time to first occurrence of the composite endpoint of all-cause mortality or hospitalization due to worsening heart failure during the 24-month follow-up period.
次要结局
- Heart Failure Functional Status(Baseline to 24 months)
- Change in Left Ventricular Ejection Fraction (LVEF)(Baseline to 24 months)
- Change in Left Ventricular End-Systolic Volume ( LV ESV)(Baseline to 24 months)
- Change in paced QRS Duration(Baseline to 24 months)
- New York Heart Association Heart Failure Functional Status(Baseline to 24 months)
研究者
Peter Ezer
MD PhD Assistant professor of Cardiology
University of Pecs