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Идёт набор NCT06540521

Bolt CSP-M Holter Study

— Наблюдательное Heart Failure Bradycardia

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: No intervention.
Кому может быть актуально
Состояния в реестре: Heart Failure, Bradycardia. Базовые параметры: от 18 лет · 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 →

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Официальное название

Intracardiac Electrical Characteristics of LBBAP

Обзор

The purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in LBB area pacing (LBBAP), from which the findings may help to develop and support data validation of a novel algorithm for LBB capture determination for LBBAP.

Подробное описание

Among LBB area pacing (LBBAP), it has been reported that left ventricular (LV) septal pacing (LVSP), which refers to a pacing approach that only captures the LV septal myocardium, produces homogeneous electrical propagation in the septum and leads to delayed LV lateral wall activation. Although large randomized trials are lacking, small observational studies have shown more preserved physiological ventricular depolarization, or superior electrical and mechanical synchrony of the LBB capture over LVSP.

During the implantation of a device, the most commonly used method to distinguish LVSP from the LBB capture is to pace with different pacing outputs. A transition will be found in the ECG morphology with changes in the LV activation time if the pacing capture threshold (PCT) of the local myocardium is different from that of the LBB (i.e., LBB-PCT), indicating a transition between capturing the LBB and LVSP without any LBB capture. So far, there is no systematic investigation on the EGM characteristics or correlation between ECG and EGM characteristics at different conduction system capture status. Findings from this study will help to better characterize EGM characteristics and to develop an optimal LBBAP modality to differentiate LBB capture.

Вмешательства

  • Другое No intervention
    No intervention

Первичные конечные точки

  • Intracardiac electrical characteristics in different pacing outputs. [Срок оценки: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment]
Вторичные конечные точки (2)
  • Intracardiac electrical characteristics under different body position. [Срок оценки: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment]
  • The correlation between LBB capture status and LBBAP EGM characteristics [Срок оценки: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment]

Критерии участия

Критерии включения

  • Patients aged >=18 years
  • Patients who are willing to provide Informed Consent
  • Patients who have received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month)
  • Patients implanted with a single/dual-chamber pacemaker or a CRT-P with LBBAP lead connected to RV port
  • Implanted device can provide at least 3-channel real-time intracardiac electrogram

Критерии исключения

  • Patients who are pregnant or have a plan for pregnancy during the study
  • Patients who have medical conditions that would limit study participation
  • Patients who were already enrolled in clinical trial(s) which would impact study participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Китай · 2 центра
  • Shanghai Chest Hospital — Шанхай
  • Zhejiang Greentown Cardiovascular Hospital — Ханчжоу

Публикации

  • Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22. PMID 29173611
  • Chen X, Qian Z, Zou F, Wang Y, Zhang X, Qiu Y, Hou X, Zhou X, Vijayaraman P, Zou J. Differentiating left bundle branch pacing and left ventricular septal pacing: An algorithm based on intracardiac electrophysiology. J Cardiovasc Electrophysiol. 2022 Mar;33(3):448-457. doi: 10.1111/jce.15350. Epub 2022 Jan 12. PMID 34978368
  • Zhou Y, Wang J, Wei Y, Zhang W, Yang Y, Rui S, Ju C. Left ventricular septal pacing versus left bundle branch pacing in the treatment of atrioventricular block. Ann Noninvasive Electrocardiol. 2022 May;27(3):e12944. doi: 10.1111/anec.12944. Epub 2022 Mar 10. PMID 35267228
  • Wu S, Chen X, Wang S, Xu L, Xiao F, Huang Z, Zheng R, Jiang L, Vijayaraman P, Sharma PS, Su L, Huang W. Evaluation of the Criteria to Distinguish Left Bundle Branch Pacing From Left Ventricular Septal Pacing. JACC Clin Electrophysiol. 2021 Sep;7(9):1166-1177. doi: 10.1016/j.jacep.2021.02.018. Epub 2021 Apr 28. PMID 33933414

Идентификаторы

NCT: NCT06540521 · MDT24030

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗