Zimerman André, Dal Forno Alexander, Rohde Luis E, Ternes Caique Mp, Alves Fernanda D, Decker Sérgio Rr, Silveira Anderson D, Damiani Lucas P, Martinelli Filho Martino, Costa Roberto, Fagundes Alexsandro A, Barbosa Rodrigo M, Gadelha Eduardo B, Lima Carlos E, Silva Márcio A, Maldonado Jaime A, de Oliveira Julio César, Mallmann Fabricio, Baggio José M, Duarte Carlos E, Zimerman Leandro I, D'Ávila André, Polanczyk Carisi A
MOVE Academic Research Organization, Hospital Moinhos de Vento, Moinhos de Vento College of Health Sciences, Porto Alegre, Brazil; Cardiology Division, Hospital Moinhos de Vento, Porto Alegre, Brazil; Postgraduate Program in Cardiology and Cardiovascular Sciences, Federal University of Rio Grande do Sul, Porto Alegre, Brazil; Hospital Moinhos de Vento, Research Projects Office, Porto Alegre, Brazil.
Hospital SOS Cardio, Florianópolis, Brazil.
Am Heart J. 2025 Dec;290:38-45. doi: 10.1016/j.ahj.2025.06.002. Epub 2025 Jun 3.
Cardiac resynchronization therapy reduces heart failure hospitalizations and mortality in patients with heart failure with reduced ejection fraction (HFrEF) and left bundle branch block (LBBB). Conduction system pacing, which directly activates the His-Purkinje system, has emerged as a safe alternative to traditional biventricular resynchronization that may offer clinical benefits at lower costs.
The PhysioSync-HF trial is an investigator-led, randomized, multicenter clinical trial designed to assess whether conduction system pacing is noninferior to biventricular resynchronization on heart failure-related outcomes in patients with HFrEF and LBBB. The study population consists of 179 adults with symptomatic heart failure (New York Heart Association [NYHA] class II-III), left ventricular ejection fraction (LVEF) ≤35%, and LBBB (QRS ≥130 ms). Patients were randomized 1:1 to receive conduction system pacing or biventricular resynchronization and followed for 12 months postprocedure. The primary endpoint is a hierarchy of all-cause death, any hospitalization for heart failure, any urgent visit for heart failure, and change in LVEF from baseline. The key secondary endpoint is the mean total direct medical cost per patient. Additional endpoints include assessments of health-related quality of life, functional capacity, and safety. Enrollment began in November 2022 and concluded in December 2023.
PhysioSync-HF will determine whether conduction system pacing is noninferior to biventricular resynchronization on heart failure-related outcomes in patients with HFrEF with LBBB.
NCT05572736.
心脏再同步治疗可降低射血分数降低的心力衰竭（HFrEF）和左束支传导阻滞（LBBB）患者的心力衰竭住院率和死亡率。直接激活希氏 - 浦肯野系统的传导系统起搏已成为传统双心室再同步治疗的一种安全替代方案，可能以更低的成本带来临床益处。
PhysioSync - HF试验是一项由研究者主导的随机多中心临床试验，旨在评估传导系统起搏在HFrEF和LBBB患者的心力衰竭相关结局方面是否不劣于双心室再同步治疗。研究人群包括179名有症状心力衰竭（纽约心脏协会[NYHA] II - III级）、左心室射血分数（LVEF）≤35%且LBBB（QRS≥130毫秒）的成年人。患者按1:1随机分组，接受传导系统起搏或双心室再同步治疗，并在术后随访12个月。主要终点是全因死亡、任何心力衰竭住院、任何心力衰竭紧急就诊以及LVEF相对于基线的变化的综合指标。关键次要终点是每位患者的平均总直接医疗费用。其他终点包括对健康相关生活质量、功能能力和安全性的评估。入组于2022年11月开始，2023年12月结束。
PhysioSync - HF试验将确定传导系统起搏在HFrEF合并LBBB患者的心力衰竭相关结局方面是否不劣于双心室再同步治疗。
NCT05572736。
