LLL vs. SDL for LBBP: A Non-inferiority RCT
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: SDL implantation, LLL implantation.
- Кому может быть актуально
- Состояния в реестре: Bradycardia, Conduction Block, Atrioventricular. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Efficacy and Safety Comparison of Lumenless Lead Versus Stylet-driven Lead in Intraoperative Application of Left Bundle Branch Pacing Guided by Continuous Pacing Monitoring With S-V Dissociation as the Primary Outcome: A Non-inferiority, Multicenter, Prospective Randomized Controlled Trial
Обзор
Left Bundle Branch Pacing (LBBP) has emerged as one of the most commonly used physiological pacing modalities in clinical practice. However, the key determinants of procedural success lie in the accurate intraoperative identification of proper LBB lead positioning and the prevention of cardiac perforation. Our previous research has established a methodology for Lumenless Lead (LLL) implantation under the guidance of continuous pacing monitoring, and this methodology has been further adapted for Stylet-driven Lead (SDL) implantation. The present study is designed as a multicenter, randomized controlled trial, aiming to compare the differences in efficacy and safety between LLL and SDL during LBBP procedures guided by continuous pacing monitoring, with the presence of S-V dissociation serving as the criterion for confirming optimal LBB lead positioning.
Вмешательства
- Процедура SDL implantation
Implantation of an SDL during LBBP procedures guided by continuous pacing monitoring, with the presence of S-V dissociation serving as the criterion for confirming optimal LBB lead positioning. - Процедура LLL implantation
Implantation of an LLL during LBBP procedures guided by continuous pacing monitoring, with the presence of S-V dissociation serving as the criterion for confirming optimal LBB lead positioning.
Первичные конечные точки
- The primary efficacy endpoint [Срок оценки: During the LBBP procedure]
- The primary safety endpoint [Срок оценки: From start of the procedure to the end of follow-up at 6 months]
Вторичные конечные точки (4)
- Procedural success rate [Срок оценки: During the procedure.]
- Abnormal parameters detected during follow-up [Срок оценки: From the start of procedure to the end of follow-up at 6 months]
- Assessment of cardiac function during follow-up [Срок оценки: From the start of procedure to the end of follow-up at 6 months]
- Assessment of quality of life. [Срок оценки: From the start of procedure to the end of follow-up at 6 months]
Критерии участия
Критерии включения
- Symptomatic sick sinus syndrome (SSS);
- Complete or advanced atrioventricular block (AVB);
- Patients with heart failure complicated by left bundle branch block (LBBB) and biventricular dyssynchrony;
- Patients with atrial fibrillation (AF) complicated by refractory rapid ventricular rate who are scheduled for atrioventricular node ablation and permanent pacemaker implantation;
- Other patients who meet the indications for dual-chamber pacemaker implantation as specified in current guidelines
Критерии исключения
- Patients who are ineligible for transvenous cardiac pacemaker implantation due to anatomical abnormalities, infections, or other factors;
- Patients with existing implantable cardiac electronic devices (ICEDs);
- Patients who opt for right-sided venous access for any reason;
- Patients with an expected survival of less than 1 year;
- Patients who have been enrolled in other clinical trials related to implantable cardiac electronic devices within 3 months prior to enrollment in this study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Ningbo No.2 Hospital — Ningbo
Публикации
- Shen J, Jiang L, Wu H, Cai X, Zhuo S, Pan L. A Continuous Pacing and Recording Technique for Differentiating Left Bundle Branch Pacing From Left Ventricular Septal Pacing: Electrophysiologic Evidence From an Intrapatient-Controlled Study. Can J Cardiol. 2023 Jan;39(1):1-10. doi: 10.1016/j.cjca.2022.09.008. Epub 2022 Sep 14. PMID 36113707
- Shen J, Jiang L, Wu H, Zhang L, Li H, Pan L. Electrophysiological characteristics of lead position-dependent electrogram uninterrupted transition during left bundle branch pacing. Heart Rhythm. 2025 May;22(5):1279-1288. doi: 10.1016/j.hrthm.2024.10.062. Epub 2024 Nov 6. PMID 39515497
- Wu H, Jiang L, Chen W, Zhuo S, Shen J, Zhang L, Zhang Y, Peng X. Short- to Mid-Term Efficacy and Safety of Left Bundle Branch Pacing Guided by Continuous Uninterrupted Paced Intracardiac Electrogram Monitoring Targeting Transition to Selective Left Bundle Branch Capture. J Cardiovasc Electrophysiol. 2025 Nov;36(11):2839-2848. doi: 10.1111/jce.70054. Epub 2025 Aug 19. PMID 40831032
- Shen J, Jiang L, Wu H, Li H. Continuous Pacing and Recording Technique: A Real-Time Feedback Approach for Left Bundle Branch Pacing. CJC Open. 2025 Jul 22;7(10):1357-1365. doi: 10.1016/j.cjco.2025.07.008. eCollection 2025 Oct. PMID 41180340
Идентификаторы
NCT: NCT07378124 · PJ-NBEY-KY-2026-014-01