Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum (POLARIS)
The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Bad Bevensen, Германия
- Herz- und Gefäßzentrum Bad Bevensen
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Girona, Испания
- Hospital Universitari de Girona Doctor Josep Trueta
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Granada, Испания
- Hospital Universitario Virgen de las Nieves
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Las Palmas de Gran Canaria, Испания
- Hospital Universitario de Gran Canaria Doctor Negrín
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Murcia, Испания
- Hospital Clínico Universitario Virgen de la Arrixaca
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Valencia, Испания
- Hospital Universitari i Politècnic La Fe
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Ferrara, Италия
- Arcispedale Sant'Anna - AO Univ.
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Novara, Италия
- Ospedale Maggiore della Carità - AO Univ.
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Taranto, Италия
- Ospedale SS Annunziata
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Treviso, Италия
- Ospedale Ca' Foncello
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Coimbra, Португалия
- ULS de Coimbra
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Lisbon, Португалия
- ULS Santa Maria
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Lisbon, Португалия
- ULS Lisboa Ocidental - Hospital de Santa Cruz
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Annecy, Франция
- Centre Hospitalier Annecy Genevois
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Clermont-Ferrand, Франция
- CHU Clermont-Ferrand
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Montpellier, Франция
- Clinique du Millénaire
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Rouen, Франция
- CHU Rouen Hôpital Charles Nicolle
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion criteria (phase I):
- Patient indicated for cardiac pacing according to the most recent guidelines from the European Society of Cardiology (ESC)
- Patient planned for a de novo implantation of any Single Chamber (SR) or Dual Chamber (DR) CE marked pacemaker
- Patient planned for a catheter-guided implantation in the interventricular septum area
- Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery catheter
- Patient reviewed, signed and dated the Informed Consent Form (ICF)
Inclusion criteria (phase II):
- Patient indicated for cardiac pacing or CRT according to the most recent guidelines from the ESC
- Patient planned for a de novo implantation of any SR or DR CE marked pacemaker, or any CE marked CRT-D
- Patient planned for a catheter-guided implantation in the interventricular septum area
- Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery catheter
- Patient reviewed, signed and dated the ICF
Exclusion criteria (phase I):
- Patient planned for a device upgrade, or a device or a lead replacement
- Patient with a congenital heart disease
- Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic cardiomyopathy
- Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35%
- Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
- Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
- Minor age patient (i.e. under 18 years of age)
- Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
- Non-menopausal women
Exclusion criteria (phase II):
- Patient planned for a device upgrade, or a device or a lead replacement
- Patient with a congenital heart disease
- Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic cardiomyopathy
- Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
- Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
- Minor age patient (i.e. under 18 years of age)
- Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
- Non-menopausal women
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Катетер доставки ФЛЕСИГО
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Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Absence of Unanticipated Serious Adverse Device Effect (USADE) related to FLEXIGO delivery catheter
Временное ограничение: 72 hours after implantation
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Any event caused by use of the FLEXIGO delivery catheter or any accessory packaged with the catheter, will be considered as an ADE related to the FLEXIGO delivery catheter. The primary endpoint evaluation will be based on Sponsor assessment of safety events, based on investigational site reporting. |
72 hours after implantation
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Implantation success rates
Временное ограничение: During implantation
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- Implantation success rate with FLEXIGO delivery catheter: Proportion of lead successfully implanted at the interventricular septum with use of the FLEXIGO delivery catheter. - Left Bundle Branch Area Pacing (LBBAP) implantation success rate with FLEXIGO delivery catheter: Proportion of lead successfully implanted at the interventricular septum with use of the FLEXIGO delivery catheter and fulfilling LBBAP success criteria according to the operator's decision. - LBBAP implantation success rate (overall): Proportion of lead successfully implanted at the interventricular septum with use of any material and fulfilling LBBAP success criteria. |
During implantation
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Implantation time
Временное ограничение: During implantation
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Total procedural time and total fluoroscopic time documented per type of cardiac device implanted and per model of catheter used. |
During implantation
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Implantation usability
Временное ограничение: During implantation
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Implantation usability of the FLEXIGO delivery catheter documented through handling scores based on a specific questionnaire addressed to the operator after implantation. |
During implantation
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Serious Adverse Device Effect (SADE) rate related to FLEXIGO delivery catheter or the slitter
Временное ограничение: 72 hours after implantation
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Proportion of SADE related to the FLEXIGO delivery catheter or the slitter. |
72 hours after implantation
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Left Bundle Branch Area Pacing (LBBAP) implantation success rate per indication (cardiac pacing and CRT) and per ventricular pacing lead model
Временное ограничение: During implantation
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- LBBAP implantation success rate with FLEXIGO delivery catheter (documented in cardiac pacing and CRT-D populations separately): Proportion of lead successfully implanted at the interventricular septum with use of the FLEXIGO delivery catheter and fulfilling LBBAP success criteria according to the operator's decision. - LBBAP implantation success rate (overall, and documented in cardiac pacing and CRT-D populations separately): Proportion of lead successfully implanted at the interventricular septum with use of any material and fulfilling LBBAP success criteria according to the operator's decision. |
During implantation
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
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
- DARI01 - POLARIS
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. .