Conduction System Stimulation to Avoid Left Ventricle Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Delta-LVEF at 6 months
研究概览
简要总结
The aim of the study is to demonstrate that conduction system pacing (CSP) can preserve a normal ventricular function compared to right ventricular apical pacing (RVAP) in patients with pre-implant preserved left ventricular ejection fraction (LVEF) and a high burden of expected ventricular pacing due to atrioventricular conduction block (AV block).
After informed consent signature, patients with high degree AV block and normal LVEF will be randomized to permanent pacemaker stimulation with CSP vs RVAP.
All the patients have a complete evaluation before the procedure and at 3 and 6 months follow-up.
详细描述
The STAY trial (Conduction System sTimulation to Avoid left ventricle dYsfunction) is a single-center, prospective, randomized, parallel, controlled study, comparing mid-term outcomes in a population undergoing pacemaker implantation due to a high degree atrio-ventricular block (AVB). The study was approved by the Hospital Ethics Committee, in accordance with the Declaration of Helsinki. All patients signed informed consent and were implanted between September 2019 until December 2022 in a 1:1 randomized fashion to conventional RVAP vs CSP (HBS or LBBS). Randomization was performed during the pre-procedural antibiotic infusion.
All the patients have a complete evaluation before the procedure and at 3 and 6 months follow-up, including demographic and clinical characteristics, physical examination, twelve-lead ECG, Minnesota score (MLWHFQ), and blood test with NT-ProBNP determination. Patients also have a transthoracic echography before the procedure and at 6 months follow-up.
At 6 months echocardiographic and clinical data will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The study is blinded for the patient and for the echocardiographers.
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 (>50%).
- •Live expectancy of more than 6 months and capability to understand the protocol, signing the informed consent form and accomplish the follow-up.
排除标准
- •Indication for implantable cardioverter defibrillator device.
- •Patients with previous LVD 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
Delta-LVEF at 6 months
时间窗: 6 months
Change in LVEF in each group at 6 months vs baseline LVEF
次要结局
- Delta-LVEDD at 6 months(6 months)
- Delta-New York Heart Association (NYHA) class at 6 months(6 months)
- Delta-NTProBNP at 6 months(6 months)
- New onset Atrial fibrillation(6 months)
- Delta-MLWHFQ (Minnesota score) at 6 months(6 months)
- Readmissions due to heart failure(6 months)
- Mortality(6 months)
研究者
Ermengol Vallès
Principal investigator
Parc de Salut Mar