Permanent Conduction System Pacing Versus Atrioventricular Management for Patients With Wide QRS and Patent AV Conduction (MORE-CSP)
Intraventricular conduction delay alone or in combination with AV conduction delay is associated with a dyssynchronous activation of the ventricles and may result in LV function impairment.
Conduction system pacing can restore physiologic ventricular activation in the presence of intraventricular and atrioventricular conduction delays.
Patients with intraventricular conduction delay alone or in combination with AV conduction delay who have a permanent pacemaker indication due to intermittent bradycardia and have predominantly intact AV conduction may benefit from continuous CSP.
Обзор исследования
Подробное описание
Study design: Multicenter, prospective, randomized, cross-over, patient-blinded study
Study Objectives:
- Primary objective: The primary objective of the study is to demonstrate that CSP is associated with better LVEF and GLS preservation at 12-month follow-up in comparison to native conduction with wide QRS. The percentages of patients with a ≥10% decline in LVEF and or ≥ 15% decline in GLS between groups will be considered for the primary outcome.
- Principal secondary objectives: NYHA class at 12 months, Walking distance in 6 minutes walking test, Quality of life (EQ EQ 5D), To evaluate reverse ventricular remodeling response and dyssynchrony parameters based on echocardiographic data at 12 months follow-up, To evaluate device battery longevity estimation at 12-month follow-up, To evaluate HF related hospitalizations/ER visits at 12 months follow-up, To evaluate mortality (global and cardiovascular) at 12-month follow-up, To evaluate incidence of ventricular arrhythmias at 12-month follow-up, To evaluate differences in LVEF and remodeling parameters depending on the final CSP modality (LBBP vs LVSP), To evaluate device related complications at 12-month follow-up, To evaluate differences between pacing indication groups (acute LBBB vs unknown/chronic wide QRS)and To evaluate percentage of patients randomized to continuous pacing who loose AV conduction after 12 months of continuous pacing Primary Endpoint: LVEF decrease ≥ 10% and/or GLS decrease ≥ 15% at 12-month follow-up with respect to baseline value
Study population criteria
- Inclusion criteria: age > 18 years, Any indication for cardiac pacing with an expected VP burden ≤ 10% after 1-month run-in period, Baseline wide QRS (≥150 ms) with normal PR or QRS ≥ 130 ms + PR≥230 ms, Confirmed CSP criteria (LBBAP including LBBP and LVSP), LVEF≥50% and Signed and dated informed consent.
- Exclusion criteria: Pregnant woman, Age < 18 years, Permanent or long-lasting atrial fibrillation, Previous PM/ICD, Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), Percutaneous Coronary Angioplasty (PCI), valve repair or replacement within 90 days prior enrollment, Moderate-severe valvular heart disease (not repaired), Already included in another clinical study that could confound the results of the present study, Infiltrative disease or any other genetically or acquired primary myocardial disease, Life expectancy < 2 years and LVEF <50%
Sample size: 120 patients will be enrolled in the study.
Devices: Only CE-marked pacemaker devices locally approved and commercially available shall be used in this protocol.
Statistical considerations: Once patients have signed the informed consent at baseline visit, patients will be considered as "Enrolled population" in the statistical analysis.
The sample size is based on the primary endpoint: LVEF decrease ≥ 10% and/or ≥ 15% decrease in GLS at 12-month follow- up with respect to baseline value.
Accounting for an attrition rate of 15% due to lost to follow-up or cross-over and considering the block size for randomization, 120 patients shall be enrolled
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Óscar Cano, MD, PhD
- Номер телефона: 440079 +34 961244000
- Электронная почта: cano_osc@gva.es
Учебное резервное копирование контактов
- Имя: Bernabé López, MD
- Номер телефона: 412713 +34 961244000
Места учебы
-
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Andalusia
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Granada, Andalusia, Испания, 18014
- Рекрутинг
- Hospital Universitario Virgen de las Nieves
-
Контакт:
- Manuel Molina, MD
- Номер телефона: +34 958020000
- Электронная почта: manuel.molina.lerma@gmail.com
-
-
Aragon
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Zaragoza, Aragon, Испания, 50009
- Рекрутинг
- Hospital Clínico Universitario Lozano Blesa
-
Контакт:
- Javier Ramos, MD
- Номер телефона: +34 976765700
- Электронная почта: javierramosmaqueda7@gmail.com
-
-
Valencia
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Valencia, Valencia, Испания, 46026
- Рекрутинг
- Hospital Universitari i Politecnic La Fe
-
Контакт:
- Óscar Cano, MD, PhD
- Номер телефона: 440079 +34 961244000
- Электронная почта: cano_osc@gva.es
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- age > 18 years
- Any indication for cardiac pacing with an expected VP burden ≤ 10% after 1- month run-in period
- Baseline wide QRS (≥150 ms) with normal PR or QRS ≥ 130 ms + PR≥230 ms
- LVEF≥50%
- Confirmed CSP criteria
- Signed and dated informed consent
Exclusion Criteria:
- Pregnant woman
- Permanent or long-lasting atrial fibrillation
- Previous PM/ICD
- Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), Percutaneous Coronary Angioplasty (PCI), surgical valve repair or replacement within 90 days prior enrollment
- Moderate-severe valvular heart disease (unrepaired)
- Already included in another clinical study that could confound the results of the present study
- Infiltrative disease or any other genetically or acquired primary myocardial disease
- Life expectancy < 2 years
- LVEF <50%
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: CSP ON
Continuous Conduction System Pacing (CSP)
|
All patients will receive a ventricular lead in the conduction system (HBP or LBBAP) using conventional implant techniques described elsewhere. The pacemaker device and leads should be implanted according to the physician's manual provided with the devices. Only locally approved Medtronic PM generators with MVP algorithms will be used during the study. Investigators will use the Medtronic Select Secure 3830 lead for CSP. Acceptable LBBAP threshold should be <2,5V@0,5ms. Other commercially available stylet driven leads may be used as bail-out strategy only when CSP cannot be achieved with the 3830 lead at the implanting physician discretion. During the implant procedure lead impedances, pacing and sensing parameters will be measured using a pacing system analyzer (PSA). It is strongly encouraged the designation of a single and experienced CSP implanting physician at each center. |
|
Плацебо Компаратор: CSP OFF
Non active Conduction System Pacing (CSP)
|
All patients will receive a ventricular lead in the conduction system (HBP or LBBAP) using conventional implant techniques described elsewhere. The pacemaker device and leads should be implanted according to the physician's manual provided with the devices. Only locally approved Medtronic PM generators with MVP algorithms will be used during the study. Investigators will use the Medtronic Select Secure 3830 lead for CSP. Acceptable LBBAP threshold should be <2,5V@0,5ms. Other commercially available stylet driven leads may be used as bail-out strategy only when CSP cannot be achieved with the 3830 lead at the implanting physician discretion. During the implant procedure lead impedances, pacing and sensing parameters will be measured using a pacing system analyzer (PSA). It is strongly encouraged the designation of a single and experienced CSP implanting physician at each center. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of patients with LVEF decrease ≥10% and/or ≥ 15% decrease in GLS at 12-month follow-up measured by echocardiographic evaluation
Временное ограничение: 12 months
|
Percentage of patients with LVEF decrease ≥10% and/or ≥ 15% decrease in GLS at 12-month follow-up measured by echocardiographic evaluation
|
12 months
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- MORE-CSP
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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