Factors Affecting Selection of Leadless Pacemaker and Atrioventricular Synchronous Pacing Status
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: Micra AV implantation.
- Кому может быть актуально
- Состояния в реестре: Pacemaker, Atrioventricular Block, Clinical Trials, Pacing. 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
Factors Affecting Selection of Leadless Pacemaker in Patients With Atrioventricular Block and Atrioventricular Synchronous Pacing Status With a Micra AV: a Multicenter, Prospective, Observational Study
Обзор
This is a multicenter, prospective, observational study ,the aim of this study is to find factors affecting selection of double-chamber leadless pacemaker in patients with atrioventricular block and ambulatory atrioventricular synchronous pacing status over time using a leadless ventricular pacemaker.
Подробное описание
Traditional pacemakers consist of a pulse generator and leads. Infections of the pulse generator pocket and lead-related complications are unavoidable issues in the application oftraditional pacemakers.Leadless pacemakers have emerged to address complications associated with the pacemaker pocket and leads in specific patients.The initial design of leadless pacemakers focused on single-chamber (right ventricular)sensing and pacing,However, patients with sinus rhythm may experience pacemakersyndrome symptoms due to atrioventricular desynchrony. Furthermore, a high proportion of atrioventricular dyssynchronous ventricular pacing might increase hospitalization rates for atrial fibrillation and heart failure.Recent developments in leadless dual-chamber pacemakersutilize a built-in triaxial accelerometer.This study aims to investigate factors considered by patients with atrioventricular block and clinical pacemaker implanting physicians when make sure the use of Micra AV. 2). It also seeks to evaluate the atrioventricular synchrony of Micra AV pacing in patients during both exercise and rest, while analyzing factors that influence the AV synchrony.For all screened patients, a questionnaire is required to be finished with data including age, gender, occupation, educational level, clinical history, comorbidities, previous infections, history of implanted electronic devices, economic status, and medical insurance conditions. At same time, all physicians are asked to complete a questionnaire for analyzing the factors influencing the decision of device option.An ambulatory electrocardiogram will be performed at 3 months, 6 months, and 1 year follow-up after device implantation. Data regarding the proportion of atrioventricular Research Protocol Template (Observational Study)\_V1.0\_2023.10.04 7/10 synchrony, atrial sensing atrial contraction mechanical wave (A4) threshold, ventricular pacing threshold, sensing, and impedance will be tested and collected. Postoperative exercise related symptoms and adverse events will be routinely tracked.
Вмешательства
- Устройство Micra AV implantation
Patients received Micra AV implantation
Первичные конечные точки
- Complete the survey questionnair before implanting a pacemaker [Срок оценки: 1 day before implanting a pacemaker]
- The percentage of atrioventricular synchrony at 3 months after Micra AV implantation. [Срок оценки: 3 months post-implant]
Вторичные конечные точки (12)
- Immediate success rate of Micra AV implantation. [Срок оценки: During implantation on day 0]
- The percentage of atrioventricular synchrony at 6, 12 months after Micra AV implantation. [Срок оценки: 6, 12 months post-implant]
- Ventricular pacing threshold, at 3 months, 6 months, and 1 year after Micra AV implantation. [Срок оценки: 3, 6, 12months post-implant]
- Ventricular sensing at 3 months, 6 months, and 1 year after Micra AV implantation. [Срок оценки: 3, 6, 12 months post-implant]
- Impedance at 3 months, 6months, and 1 year after Micra AV implantation. [Срок оценки: 3, 6, 12 months post-implant]
- Major complications related to the device implantation at perioperative period, and 3, 6, 9, 12 months after Micra AV implantation [Срок оценки: Days 0,1 and 3, 6, 9, 12 months post- implant]
- All-cause mortality rates at 3 months, 6 months, and 1 year after Micra AV implantation. [Срок оценки: 3, 6, 9, 12 months post-implant]
- Rehospitalization events related to heart failure at 3 months, 6 months, and 1year after Micra AV implantation. [Срок оценки: 3, 6, 12 months post-implant]
- Tachycardia related to the pacemaker, or adverse events related to the device or algorithm at 3, 6, 12 months after Micra AV implantation. [Срок оценки: 3,6,12 months post-implant]
- Left venriculat ejection fraction measured by echocardiography at 6, 12 months after Micra AV implanted [Срок оценки: 6, 12 months post-implant]
- Left ventricular end-diastolic diameter measured by echocardiography at 6, 12 months after Micra AV implantation. [Срок оценки: 6, 12 months post-implant]
- Parameter adjustment events related to the synchrony less than 70% at 3, 6, 12 months after Micra AV implantation.. [Срок оценки: 3, 6, 12months post-implant]
Критерии участия
Критерии включения
- Patients diagnosed with atrioventricular conduction block, meeting the indications for dual-chamber leadless pacemakers as per the "Chinese Expert Consensus on Clinical Application of Leadless Pacemakers (2022)".
- Age ≥18 years.
- Expected lifespan ≥1 year.
- Consent to sign an informed consent form and cooperate in the collection of baseline data and subsequent follow-ups
Критерии исключения
- Patients anticipated to have a high ventricular pacing proportion (>40%) and with left ventricular ejection fraction less than 50%.
- Patients with persistent atrial fibrillation and a high expected ventricular pacing proportion.
- Post-tricuspid valve mechanical valve replacement surgery.
- Patients with inferior vena cava pathway anomalies, precluding passage of the leadless pacemaker's delivery sheath.
- Patients with an expected lifespan of less than 1 year. 6 Patients who are pregnant, planning pregnancy, or undergoing cardiac transplantation.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Китай · 2 центра
- Fu Wai Hospital — Пекин
- Peking University First Hospital — Пекин
Публикации
- Wilkoff BL. How to treat and identify device infections. Heart Rhythm. 2007 Nov;4(11):1467-70. doi: 10.1016/j.hrthm.2007.08.007. Epub 2007 Aug 11. No abstract available. PMID 17954409
- Johansen JB, Jorgensen OD, Moller M, Arnsbo P, Mortensen PT, Nielsen JC. Infection after pacemaker implantation: infection rates and risk factors associated with infection in a population-based cohort study of 46299 consecutive patients. Eur Heart J. 2011 Apr;32(8):991-8. doi: 10.1093/eurheartj/ehq497. Epub 2011 Jan 20. PMID 21252172
- Knops RE, Tjong FV, Neuzil P, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Reddy VY. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol. 2015 Apr 21;65(15):1497-504. doi: 10.1016/j.jacc.2015.02.022. PMID 25881930
- Reddy VY, Knops RE, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Tjong FV, Jacobson P, Ostrosff A, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Neuzil P. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. 2014 Apr 8;129(14):1466-71. doi: 10.1161/CIRCULATIONAHA.113.006987. Epub 2014 Mar 24. PMID 24664277
- Reynolds DW, Ritter P. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. 2016 Jun 30;374(26):2604-5. doi: 10.1056/NEJMc1604852. No abstract available. PMID 27355552
- Ann HW, Ahn JY, Jeon YD, Jung IY, Jeong SJ, Joung B, Lee M, Ku NS, Han SH, Kim JM, Choi JY. Incidence of and risk factors for infectious complications in patients with cardiac device implantation. Int J Infect Dis. 2015 Jul;36:9-14. doi: 10.1016/j.ijid.2015.05.011. Epub 2015 May 14. PMID 25980618
Идентификаторы
NCT: NCT06587672 · 2024-ZX028