A Comparison of Left Bundle Branch Optimized Cardiac Resynchronization Therapy vs Left Bundle Branch Area Pacing Alone (LOT or NOT)
Left bundle branch area pacing (LBBAP) has emerged as a promising physiological pacing strategy and may offer advantages over conventional biventricular pacing (BVP), including improved clinical outcomes. However, its effectiveness may be limited in patients with distal conduction system disease, significant endocardial and/or myocardial damage, as well as when direct left bundle branch capture is not achieved. Conventional CRT remains an effective therapy but is associated with procedural challenges and a significant non-responder rate. Current guidelines support the use of LBBAP and BVP either individually or in combination as Left Bundle Branch Optimized CRT (LOT-CRT). Recent data suggest that LOT-CRT may provide superior electrical and hemodynamic resynchronization compared with both LBBAP and BVP. However, there is a lack of randomized trials comparing LBBAP and LOT-CRT in patients with CRT-P indication. The aim of this study is to compare the LOT-CRTP to LBBAP alone.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Guram PD Dr. Imnadze
- 电话号码：+491733728489
- 邮箱：g.imnadze@ukrb.de
学习地点
-
-
Brandenburg
-
Neuruppin、Brandenburg、德国、16816
- University Hospital Ruppin-Brandenburg
-
接触：
- Guram Imnadze, MD, PhD
- 电话号码：+493391393111
- 邮箱：imnadze@web.de
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Age ≥ 18 years Clinical indication for CRTP implantation according to the current ESC guidelines De novo implantation LBBB (QRS duration ≥130 ms) NYHA II-IV
Exclusion Criteria:
Severe mitral or aortic valvular disease History of VT/VF Failed implantation of any component of the LOT-CRTP system/ incompleteness of the system to be implanted Pregnancy Life expectancy < 1 year Inability to give written consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：LOT group
LOT group: Implanted with LOT-CRT-P device and programmed with maximum RV-LV synchronization with narrowest QRS complex on the 12-lead ECG. |
Device: LOT-CRT-P (Programming: LOT-CRT-P) All patients will receive implantation of LOT-CRT-P system consisting of a CRT-P device, CSP lead placed in the LBBAP position in the right ventricle (instead of conventional RV lead), LV lead placed in the coronary sinus, and right atrial lead. Device programming: LOT group: Pacing with maximum RV-LV synchronization with narrowest QRS complex on the 12-lead ECG. After 12 months and study end, each patient receives a personalised and optimally tailored adjustment. |
|
其他：NOT group (LBBAP)
NOT group: Implanted with LOT-CRT-P device and programmed with LBBAP only along with the backup pacing of LV lead with RV-LV delay of 80-100ms. |
All patients will receive implantation of LOT-CRT-P system consisting of a CRT-P device, CSP lead placed in the LBBAP position in the right ventricle (instead of conventional RV lead), LV lead placed in the coronary sinus, and right atrial lead. Device programming: NOT group: Synchronized with LBBAP only along with the backup pacing of LV lead with RV-LV delay of 80-100ms. After 12 months and study end, each patient receives a personalised and optimally tailored adjustment. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Clinical Status
大体时间：From enrollment to 12 month follow up
|
Hierarchical clinical composite score: 1. Patients who died for a cardiovascular cause, received a heart transplantation or had an unplanned emergency department visit or hospitalization for heart failure are 'unchanged/worsened'. 2. Patients who receive a modification of the implanted CRTP system for reasons of presumed inefficacy of the randomized system are 'unchanged/worsened'. 3. Patients to whom the above does not apply and who have >20% absolute increase in LVEF at 12 months or earlier are 'markedly improved', and patients who have <5% absolute increase in LVEF at 12 months are 'unchanged/worsened' 4. Patients to whom the above does not apply the KCCQ-12 overall summary score will be assessed. Those who have ≥ 5 points increase in KCCQ-12 overall summary score are 'markedly improved', and patients who have ≥5 points decrease are 'unchanged/worsened'. 5. Patients for whom none of the conditions above apply, are 'moderately improved'. |
From enrollment to 12 month follow up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Electrocardiographic characteristics
大体时间：enrollment to 12 month follow up
|
ECG: QRS duration, assessment of LV lateral wall activation time and LV lateral wall to RV septal activation time. |
enrollment to 12 month follow up
|
|
Echocardiographic characteristics
大体时间：enrollment to 12 month follow up
|
left ventricular ejection fraction (LVEF), left ventricular end-systolic/ end-diastolic volume (LVESV/LVEDV), LV EDD, LV ESD. |
enrollment to 12 month follow up
|
|
NYHA class
大体时间：enrollment to 12 month follow up
|
enrollment to 12 month follow up
|
|
|
NT-ProBNP
大体时间：enrollment to 12 month follow up
|
enrollment to 12 month follow up
|
|
|
6 minutes walking test
大体时间：enrollment to 12 month follow up
|
enrollment to 12 month follow up
|
|
|
Quality of Life Questionaire
大体时间：enrollment to 12 month follow up
|
KCCQ-12 |
enrollment to 12 month follow up
|
|
Worsened heart failure
大体时间：enrollment to 12 month follow up
|
enrollment to 12 month follow up
|
|
|
Arrhythmic events
大体时间：enrollment to 12 month follow up
|
VT/VF/AF occurrence |
enrollment to 12 month follow up
|
|
Mortality
大体时间：enrollment to 12 month follow up
|
enrollment to 12 month follow up
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.