LEft VEntricuLar Activation Time Shortening With Physiological Pacing vs Biventricular Resynchronization Therapy: a Randomized Study (LEVEL-AT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Left ventricular activation time.
研究概览
简要总结
The LEVEL-AT Trial (LEft VEntricuLar Activation Time Shortening with Physiological Pacing vs Biventricular Resynchronization therapy: a randomized study) is a non-inferiority study that aims to determine if physiological pacing could decrease the left ventricular activation time compared with biventricular therapy.
详细描述
To date studies have showed that physiological pacing could get similar clinical and echocardiographic response to that obtained with biventricular therapy. Activation time shortening with permanent physiological pacing has not been studied.
This study will randomize 70 patients to a strategy of: biventricular pacing versus physiological pacing.
LEVEL-AT study will analyze the following parameters in the 2 groups: shortening of the QRS, activation time with electrocardiographic imaging, echocardiographic asynchrony and ventricular function and clinical parameters (NYHA functional class, mortality and heart failure hospitalization).
Clinical, electrocardiographic, echocardiographic and electrocardiographic imaging follow-up will be performed for 1 year.
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
- Single (Participant)
盲法说明
The patient will be explained to be randomized to either of the two branches. The type of therapy applied will not be communicated to the patient. The follow-up will be the same in the two branches. During the visits it will not be said which therapy has been applied.
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
- •The patient must indicate their acceptance to participate in the study by signing an informed consent document.
- •The patient must be ≥ 18 years of age.
- •Left bundle branch block, QRS ≥130 and FEVI <=35% (Indication of cardiac resynchronization IA or IB ESC Guidelines). No indication of stimulation for AV block.
- •Patients with indication of resynchronization therapy for ventricular dysfunction and indication of cardiac stimulation for AV block according to ESC Guidelines (IA ESC Guidelines).
- •Non-left bundle branch block, QRS ≥150 and FEVI <=35% (Indication of cardiac resynchronization IIaB ESC Guidelines).
排除标准
- •Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
- •Pregnancy.
- •Participating currently in a clinical investigation that includes an active treatment.
结局指标
主要结局
Left ventricular activation time.
时间窗: 45 days
Left ventricular activation time measured by eletrocardiographic imaging.
次要结局
- Hospitalization due to heart failure or mortality (combined endpoint).(1 year.)
- Change in end-systolic volume.(6 months and 12 months.)
- Correction of septal flash(15 days)
- Left ventricular activation time.(6 months and 12 months.)
- Change in left ventricular function.(6 months and 12 months.)
- QRS duration.(Implant, 6 months and 12 months.)
- Change in NYHA functional class.(6 months and 12 months.)
研究者
Josep Lluis Mont Girbau
Head of Arrhythmia Section. Professor of Cardiology
Hospital Clinic of Barcelona