Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction. A Multicenter Randomized Trial From the STAY Investigators
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- LVEF evolution
研究概览
简要总结
Right ventricular apical pacing (RVAP) can produce left ventricular dysfunction (LVD). Conduction system pacing (CSP) has been used successfully to reverse LVD in patients with left bundle branch block. A recent randomized controlled trial (RCT) has demonstrated that CSP, mostly performed with left bundle branch area pacing (LBBAP), can preserve normal ventricular function and heart failure admissions compared to RVAP in the setting of a high burden of ventricular pacing11 (Stay Trial).
Criteria to assess the LBBAP distinguishes those cases in which the LBB is captured (LBBP) from those in which only the muscular septum surrounding the LBB is captured (LVSP). To date, data regarding LVSP to preserve left ventricle ejection fraction (LVEF) is scarce and limited to non-randomized studies.
详细描述
Conventional right ventricular apical pacing (RVAP) can produce electrical and mechanical dysynchrony, which may lead to left ventricle dysfunction (LVD) in up to 12% of patients with normal left ventricle ejection fraction (LVEF). A high burden on RVAP is a major predictor of developing LVD, atrial fibrillation (AF), heart failure (HF), and mortality. CSP is able to preserve a more physiological pattern of cardiac electrical activation, utilizing the native conduction system network, or correcting a bundle branch block morphology in patients with disturbances at a proximal or intermediate level of the conduction system network.
The aim of the study is to demonstrate that LVSP can preserve ventricular function compared to LBBP in patients with preserved or mildly deteriorated LVEF and a high burden of expected ventricular pacing. A second hypothesis is to demonstrate than both LVSP and LBBP are both superior to RVAP.
Study design The STAY II trial is a multi-center, prospective, randomized, parallel, controlled study, comparing 12 months outcomes in a population undergoing pacemaker implantation due to a high degree atrio-ventricular block (AVB). All patients will sign informed consent and will be implanted with a pacemaker in a 1:2 randomized fashion to conventional RVAP vs LBBAP (LBBP or LVSP). Randomization to RVAP or LBBAP will be performed during the pre-procedural antibiotic infusion. Patients allocated in the LBBAP group will be evaluated after the procedure and classified as LBBP or LVSP upon the accomplishment of the accepted criteria for LBBAP (consensus).
Consecutive patients requiring permanent pacemaker implantation due to high degree AVB according to current guidelines will be evaluated for inclusion in the study. All patients need to fit all inclusion criteria and none of the exclusion criteria.
Location of the right ventricle pacing lead. Right ventricle apical pacing (RVAP): Capture of the RV by apex stimulation, generating a QRS with LBBB morphology and superior axis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years or more.
- •Preserved or mild deteriorated LVEF (Simpson >40%) assessed by a recent (<1 month before implantation) transthoracic echocardiography.
- •Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (>80%).
- •Life expectancy of more than 12 months and capability to understand the protocol, signing informed consent form, and complying with follow-up.
排除标准
- •Patients with indication for implantable cardioverter defibrillator device.
- •Patients with indication for a CRT device, with LVEF <40%.
- •Patients with previous severe LVD (Simpson LVEF <30%) and a recovered LVEF.
- •History of myocardial infarction/revascularization or cardiac surgery within 6 months before randomization.
- •Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.
结局指标
主要结局
LVEF evolution
时间窗: At 12 months after the pacemaker implantation
Change in the value (%) of LVEF at 12 months compared to basal
Admission due to HF
时间窗: From date of implantation until the date of first admission due to HF, whichever came first, assessed up to 12 months
Hospital admission due to episode of heart failure (new onset HF or worsening from baseline NYHA)
次要结局
- LVEED evolution(At 12 months after the pacemaker implantation)
- Admission due to AF(From date of implantation until the date of first admission due to AF, whichever came first, assessed up to 12 months)
研究者
Ermengol Vallès
Director of Electrophysiology and Cardiac Stimulation Program
Parc de Salut Mar