БОСТОНСКИЙ НАУЧНЫЙ РЕГИСТР УПРАВЛЕНИЯ РИТМАМИ (SOCRATES) (SOCRATES)
БОСТОНСКИЙ НАУЧНЫЙ РЕГИСТР УПРАВЛЕНИЯ РИТМОМ
SOCRATES is part of Boston Scientific's (BSC) Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices' or short Medical Device Regulation (MDR). The SOCRATES design is therefore based on the BSC's commitment as well as external regulatory requirements to proactively and systematically gather, record and analyze relevant data on the quality, performance and safety of devices throughout their entire lifetime.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
SOCRATES is a non-randomized, multisite, single-arm, open-label, global post-market observational data collection per standard of care. While generally of prospective design, a limited retrospective element is allowed for the inclusion of patients for a short period of 10 days after their index procedure.
SOCRATES intends to enroll a number of subjects that will support the analysis of all the individual Post Market Clinical Follow-Up (PMCF) Plans. An average of approximately 100 subjects per year and site on a continuous basis is expected but may vary depending on the needs of individual PMCF Plans. As long as SOCRATES is active, there is no upper limit to the total number of subjects that may be enrolled, and enrollment will be driven by the need to support sample sizes of individual PMCF plans for given products/product groupings supported by SOCRATES.
SOCRATES is designed to be a continuous effort after the data collection commences without a predefined closure timepoint. Data collection and enrollment may be stopped, restarted or finalized per Sponsor discretion.
The expected duration of SOCRATES participation for a subject is dependent on
- the specific lifetime of the device (e.g. the battery usage for pulse generators or continued active use of leads for CRM devices) or
- the necessary timeframe to adequately assess safety and performance of the device based on the residual risk assessed for each device in the associated PMCF plan. Timeframes might e.g. spread from 7 days to one year post procedure for EP. The maximum duration per enrolled subject will consequently vary.
For BSC implantable devices subjects are intended to be followed for the entire time of being implanted with a BSC device to allow data collection over the lifetime of the device(s) as required by applicable regulations. A maximum duration per enrolled subject is not defined, unless locally required. In case a local maximum duration is enforced subjects may be consented again and re-enrolled for continued participation if they are still in scope for SOCRATES. Sites shall ensure continuous data collection without any gaps in case a re-enrollment becomes applicable. Data sets for re-enrolled subjects will be handled as if the subject was continuously enrolled. This process will ensure to meet the requirement of MDR for device manufacturers to collect data over the lifetime of the devices.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Maria Paz Lopez-Chicharro
- Номер телефона: 1-800-227-3422
- Электронная почта: maria.lopez-chicharro@bsci.com
Учебное резервное копирование контактов
- Имя: Jens B Goetzke, Dipl.Ing.
- Номер телефона: 1-800-227-3422
- Электронная почта: Jens.Goetzke@bsci.com
Места учебы
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Jette, Бельгия, 1090
- Рекрутинг
- Universitair Ziekenhuis Brussel
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Контакт:
- Carlo de Asmundis, Prof.
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Yvoir, Бельгия, 5530
- Рекрутинг
- CHU UCL Namur - Site Godinne
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Контакт:
- Dominique Blommaert, Prof.
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Berlin, Германия, 12687
- Рекрутинг
- Unfallkrankenhaus Berlin Marzahn
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Контакт:
- Corinna Lenz, MD
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Bochum, Германия, 44791
- Завершенный
- Augusta Kranken Anstalt GmbH
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Athens, Греция, 17674
- Рекрутинг
- Onassis Cardiac Surgery Center
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Контакт:
- Michael Ephremidis, MD
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Athens, Греция, 11527
- Завершенный
- General Hospital of Athens "G. Gennimatas"
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Ramat Gan, Израиль, 52621
- Рекрутинг
- Sheba Medical Center
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Контакт:
- Roy Beinart, MD
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Tel Aviv, Израиль, 6423906
- Рекрутинг
- Tel Aviv Sourasky Medical Center
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Контакт:
- Raphael Rosso, Professor
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Tel Aviv, Израиль, 62431
- Рекрутинг
- Tel Aviv Sourask Medical Center
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Контакт:
- Raphael Rosso, Professor
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Dublin, Ирландия, D07 WKW8
- Рекрутинг
- Mater Private Hospital
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Контакт:
- Gabor Szeplaki, Prof.
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Madrid, Испания, 28040
- Рекрутинг
- Hospital Clinico San Carlos
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Контакт:
- Nicasio Pérez Castellano, MD
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San Cristóbal de La Laguna, Испания, 38320
- Рекрутинг
- Hospital Universitario de Canarias
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Контакт:
- Francisco Bosa Ojeda, MD
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Santa Cruz de Tenerife, Испания, 38010
- Рекрутинг
- Hospital Nuestra Señora de La Candelaria
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Контакт:
- Luis A. Acosta, MD
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Zaragoza, Испания, 50009
- Рекрутинг
- Hospital Universitario Miguel Servet
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Контакт:
- Antonio Asso Abadía, MD
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Modena, Италия, 41124
- Рекрутинг
- Policlinico di Modena
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Контакт:
- Giuseppe Boriani, Prof.
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Roma, Италия, 00168
- Рекрутинг
- Policlinico Universitario Agostino Gemelli
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Контакт:
- Gemma Pelargonio, MD
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Roma, Италия, 00169
- Рекрутинг
- Policlinico Casilino
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Контакт:
- Leonardo Calò, MD
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Roma, Италия, 00186
- Рекрутинг
- Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina
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Контакт:
- Stefano Bianchi, MD
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Quebec
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Québec, Quebec, Канада, G1V 4G5
- Рекрутинг
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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Контакт:
- Jean-Francois Sarrazin, MD
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London, Соединенное Королевство, EC1A 7BE
- Рекрутинг
- St. Bartholomew's Hospital
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Контакт:
- Ross Hunter, Prof.
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Manchester, Соединенное Королевство, M13 9WL
- Рекрутинг
- Manchester Heart Center
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Контакт:
- Charles Pearman, MD
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Brest, Франция, 29200
- Рекрутинг
- CHRU de Brest, Hôpital de la Cavale Blanche
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Контакт:
- Jacques Mansourati, Prof.
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Clermont-Ferrand, Франция, 63000
- Рекрутинг
- CHRU de Clermont-Ferrand
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Контакт:
- Romain Eschalier, MD
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Lomme, Франция, 59462
- Рекрутинг
- Hopital Saint Philibert
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Контакт:
- Aymeric Menet, MD
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Pau, Франция
- Рекрутинг
- CHG de Pau
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Контакт:
- Hugues Bader, MD
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Saint-Etienne, Франция, 42055
- Рекрутинг
- CHU de Saint-Etienne
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Контакт:
- Antoine Da Costa, Prof.
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
The subjects will be recruited from the general patient population of the participating centers who are
- receiving diagnosis or treatment using a BSC product in scope of SOCRATES and
- fulfilling all inclusion criteria and none of the exclusion criteria.
Описание
Inclusion Criteria:
- Subject is willing and capable of providing informed consent and/or to give approval to collect/store/process personal health information by the sponsor or such consent/approval is provided by a legally designated representative, if required by local law or regulation.
- Subject is (one criterion must be fulfilled) a. prospectively scheduled for a procedure involving i. use of a BSC EP Ablation product or BSC Capital Equipment product or ii. a BSC CRM product implant or b. retrospectively enrolled no more than 10 days after the index procedure and all data necessary for appropriate reporting of all past visits is available and complete including i. the procedure where being diagnosed or treated with at least 3 separate BSC EP Ablation products/components or BSC Capital Equipment products/components or ii. the BSC CRM product implant.
Exclusion Criteria:
- Subject is foreseen not to be followed at the enrolling center for at least 1 year after an implant procedure (CRM) or at least 1 month (EP).
- Subject is receiving diagnosis or therapy by means of any product, that is not approved for commercial use at the time of implant/procedure.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: OTHER
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
BSC Product Use
Subject fulfilling one of the following conditions: a. prospectively scheduled for a procedure involving i. use of a BSC EP Ablation product or BSC Capital Equipment product or ii. a BSC CRM product implant or b. retrospectively enrolled no more than 10 days after the index procedure and and all data necessary for appropriate reporting of all past visits is available and complete including i. the procedure where being diagnosed or treated with at least 3 separate BSC EP Ablation products/components or BSC Capital Equipment products/components or ii.the BSC CRM product implant. |
In the scope of the CRM procedure and subsequent follow-up, the registry will provide information on the use of the Boston Scientific CRM products/components and combination of those products/components with competitor product(s) per hospital's standard of care. In the scope of the EP procedure and subsequent follow-up, the registry will provide information on the use of the Boston Scientific Electrophysiology products/components and capital equipment products and combination of those products/components with competitor product(s) per hospital's standard of care. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
System-related complication free rate
Временное ограничение: From Cardiac Rhythm Management (CRM) device implant on day 0 through follow-up up to 10 years; from electrophysiological (EP) procedure on day 0 through follow-up from 30 days up to 1 year
|
Freedom from complications related to system |
From Cardiac Rhythm Management (CRM) device implant on day 0 through follow-up up to 10 years; from electrophysiological (EP) procedure on day 0 through follow-up from 30 days up to 1 year
|
|
Rate of product related performance deficiencies per product or product group
Временное ограничение: CRM implant on day 0; EP procedure on day 0
|
Performance of product/product group at implant/procedure |
CRM implant on day 0; EP procedure on day 0
|
|
Rate of product related performance deficiencies per product or product group
Временное ограничение: CRM implant on day 0 through the implanted duration up to 10 years
|
Performance of product/product group through the implanted duration |
CRM implant on day 0 through the implanted duration up to 10 years
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Eszter Pais, MD, Boston Scientific Corporation
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
- SOCRATES - C2157
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.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .