A Non-inferiority Randomized Comparison Between LEFT BUNDLE Branch Area Pacing and Biventricular Pacing for Cardiac Resynchronization Therapy: The LEFT-BUNDLE-CRT Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 176
- 试验地点
- 18
- 主要终点
- CRT response
研究概览
简要总结
Cardiac resynchronization therapy (CRT) via biventricular (BiV) pacing significantly reduces morbidity and mortality in patients with left bundle branch block (LBBB), impaired LV function and heart failure in spite of optimal medical treatment. CRT positive effects are based on the existence of an electromechanical dyssynchrony induced by the abnormal activation sequence associated with the presence of a left bundle branch block (LBBB), which is thought to be responsible for a negative LV remodeling leading to LVEF impairment and heart failure progression. However, one third of patients undergoing CRT are considered non responders due to different reasons. Recently, left bundle branch area pacing (LBBAP) has emerged as a novel physiological pacing modality aiming for conduction system recruitment in patients with normal or impaired atrioventricular conduction, including patients with LBBB. LBBAP achieves LBBB correction in up to 85% of the cases and thus could be a promising pacing modality for CRT candidates.
详细描述
Medical device: Only CE-marked CRT-P or CRT-D Medtronic devices locally approved and commercially available (Medtronic 3830 Pacing Lead) shall be used in this protocol.
Indication: Pacing and sensing in the right atrium or ventricle. It is also designed for pacing and sensing in the bundle as an alternative to pacing in the right ventricle in a single or dual chamber pacing system.
Intended use: Patients with an indication for cardiac resynchronization therapy.
Duration of the study: Approximate inclusion period of 18 months
Follow-up: Patients will be followed for 12 months ± 4 weeks after implant
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
- 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 > 18 years
- •Class I or IIa indication for CRT according to current ESC or ACC/AHA/HRS guidelines
- •left bundle branch block according to Strauss criteria
- •Signed and dated informed consent
排除标准
- •Pregnant woman
- •Permanent or long-lasting atrial fibrillation
- •Previous CRT device
- •Previous PM/ICD with ventricular pacing > 10%
- •Conventional pacemaker indication
- •Nonspecific IVCD (intraventricular conduction delay)
- •Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), Percutaneous Coronary Angioplasty (PCI), valve repair or replacement within 90 days prior enrollment
- •Indication for valve repair or replacement
- •Already included in another clinical study that could confoud the results of the present study
- •Life expectancy < 12 months
结局指标
主要结局
CRT response
时间窗: 6 months follow-up
Positive CRT response will be defined either by an improved Clinical Composite Score or ≥15% reduction in left ventricular end-systolic volume
次要结局
- Exercise capacity(6 and 12 months follow-up)
- Left ventricular ejection fraction(6 and 12 months follow-up)
- Clinical outcome(6 and 12 months follow-up)
- Heart Failure Hospitalizations(6 and 12 months follow-up)
- Cardiac transplantation(6 and 12 months follow-up)
- Ventricular arrhythmias(6 and 12 month follow-up)
- Device related complications(6 and 12 month follow-up)
- Ventricular arrhythmias(6 and 12 month follow-up)
- Left ventricular ejection fraction(6 and 12 months follow-up)
- Clinical outcome(6 and 12 months follow-up)
- Exercise capacity(6 and 12 months follow-up)
- The EQ-5D three-level version (EQ-5D-3L)(6 and 12 months follow-up)
- Heart Failure Hospitalizations(6 and 12 months follow-up)
- Mortality(6 and 12 months follow-up)
- Cardiac transplantation(6 and 12 months follow-up)
- Device related complications(6 and 12 month follow-up)
研究者
Óscar Cano Pérez
Cardiologist
Spanish Society of Cardiology