A Comparison of Left Bundle Branch Optimized Cardiac Resynchronization Therapy vs Left Bundle Branch Area Pacing Alone
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Clinical Status
研究概览
简要总结
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
patients and implanting cardiologist will be blinded
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 Clinical indication for CRTP implantation according to the current ESC guidelines De novo implantation LBBB (QRS duration ≥130 ms) NYHA II-IV
排除标准
- •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
研究组 & 干预措施
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.
干预措施: LOT-CRT-P (Programming: LOT-CRT-P) (Device)
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.
干预措施: LOT-CRT-P (Programming: LBBAP) (Device)
结局指标
主要结局
Clinical Status
时间窗: 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'.
次要结局
- Electrocardiographic characteristics(enrollment to 12 month follow up)
- Echocardiographic characteristics(enrollment to 12 month follow up)
- NYHA class(enrollment to 12 month follow up)
- NT-ProBNP(enrollment to 12 month follow up)
- 6 minutes walking test(enrollment to 12 month follow up)
- Quality of Life Questionaire(enrollment to 12 month follow up)
- Worsened heart failure(enrollment to 12 month follow up)
- Arrhythmic events(enrollment to 12 month follow up)
- Mortality(enrollment to 12 month follow up)
研究者
PD Dr. Guram Imnadze
Chief Physician of the Medical Clinic A- Rhythmology
Universitatsklinikum Ruppin-Brandenburg GmbH