LEFT Bundle Pacing vs Standard Right Ventricular Pacing for Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Time to first heart failure event
研究概览
简要总结
High burden right ventricular (RV) pacing has been shown to increase cardiovascular mortality, incidence of heart failure (HF), worsen left ventricular (LV) function and accelerate the development of atrial fibrillation (AF). High percentage ventricular pacing and wider paced QRS in the setting of normal baseline LV ejection fractions have consistently been shown to be independent risk factors for pacing-induced cardiomyopathy. Left bundle branch pacing (LBBP) has emerged as a potential alternative pacing mechanism that may avoid LV dyssynchrony and pacing-induced LV dysfunction by mimicking native electrical conduction.
详细描述
We hypothesize that in patients with high degree AV block with anticipated ventricular pacing >90%, and an EF >35% patients undergoing LBBP will demonstrate a significantly lower number of the primary composite endpoint of cardiovascular death, heart failure events, and change in LVESVi as compared to standard RV pacing. Echos will be performed at baseline, 12, 24, and 36 months. NTproBNPs are performed at baseline and follow-up. There will be a core echo lab, and blinded adjudication of ECGs and events.
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 (Outcomes Assessor)
盲法说明
Blinded outcome adjudication
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
- •Patients with an ejection fraction of >35%
- •Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is >90% including:
- •Third degree AV block
- •Symptomatic or asymptomatic second-degree AV block
- •First degree AV block ≥ 280ms with a narrow QRS, or ≥ 240ms with an intraventricular delay (QRS duration ≥120ms)
- •Echocardiogram within the last 3 months, with ability to have DICOM images
排除标准
- •Indication for an implantable cardioverter defibrillator
- •Presence of a mechanical tricuspid valve
- •Any prior attempt at implantation of an ICD, CRT, HBP, or LBBP
- •Lack of capacity to consent
- •Other serious medical condition with life expectancy of <2 years
- •Patients in whom the conduction system abnormality is expected to be transient or recover over time
- •Patients with permanent atrial fibrillation
研究组 & 干预措施
left bundle branch pacing
干预措施: Left bundle branch pacing lead (Device)
Right ventricular pacing
干预措施: Right ventricular active fixation lead (Device)
结局指标
主要结局
Time to first heart failure event
时间窗: 36 months
Defined as: (i) Emergency department (ED) visits or hospitalization for HF (requiring signs and symptoms consistent with congestive heart failure (CHF) that is responsive to oral or parenteral medications); (ii) intensification of therapy (intravenous diuretic therapy on an outpatient basis); or (iii) indication for device upgrade to CRT due to deteriorating LV function defined as an absolute decline in LVEF ≥ 10% from baseline and an LVEF ≤ 40%
Time to cardiovascular death
时间窗: 36 months
Clinical
Worsening LV end systolic volume index by 2 years
时间窗: 24 months
Defined as a 15% increase from baseline each year up to the two-year echo
次要结局
- Cardiovascular mortality(24 months)
- Atrial fibrillation progression(24 months)
- Change in NTproBNP level(24 months)
- Development of new tricuspid regurgitation(24 months)
- Change in Lead parameter(24 months)
- New visit for Heart Failure(24 months)
- Presence of Mitral regurgitation(24 months)
- Quality of Life Improvement(Evaluated at 1, 12, and 24 months, measure as compared to baseline)
- Total mortality(24 months)
- Change in left ventricular ejection fraction(24 months)
- Safety of procedure and long-term safety(24 months)
研究者
Jacqueline Joza
Cardiac electrophysiologist
McGill University Health Centre/Research Institute of the McGill University Health Centre