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Идёт набор NCT06953206

Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve

— Наблюдательное Transcatheter Aortic Valve Replacement (TAVR) Aortic-Stenosis Aortic Insufficiency Degenerative Valve Disease

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: Transcatheter aortic valve (S3UR) replacement (TAVR).
Кому может быть актуально
Состояния в реестре: Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis, Aortic Insufficiency, Degenerative Valve Disease. 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
Германия
Следующий шаг
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Официальное название

SAPIEN Ultra RESILIA Durability EU Registry - The RESOUND-EU Registry

Обзор

Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.

Подробное описание

Transcatheter aortic valve replacement (TAVI) has become the gold standard treatment for moderate-to-high risk elderly patients with severe symptomatic aortic stenosis. Based on the results of randomized trials including low risk patients, this treatment has been progressively applied to younger (in the sixties and seventies) patients with a low co-morbidity burden. Life expectancy in this group is expected to extend beyond 5 years from intervention in the vast majority of patients, and beyond 10 years in a high proportion. Thus, the issue of valve durability has become one of the most important aspects in the TAVI field in recent years. To date, the rates of bioprosthetic valve failure at 8-10 years after TAVI have been consistently \<10%, but some studies have shown some degree of valve structural degeneration in close to one third of the patients at 8-year follow-up. This subclinical valve degeneration before the 10-year follow-up landmark would represent the initial step in the process of bioprosthetic valve failure, and further valve degeneration leading to clinical symptoms is likely to occur in a significant proportion of these cases.

This prospective registry will evaluate the clinical outcomes and the valve performance of the SAPIEN 3 Ultra RESILIA valve over 10 years.

Вмешательства

  • Процедура Transcatheter aortic valve (S3UR) replacement (TAVR)
    Elective transfemoral TAVi procedure with S3UR valve.

Первичные конечные точки

  • Early Safety [Срок оценки: 1-3 months]
  • Device Success [Срок оценки: 1-3 months]
  • Bioprosthetic Valve Failure [Срок оценки: 3-5 years]
  • Bioprosthetic Valve Failure [Срок оценки: 9-10 years]
  • Structural Valve Deterioration [Срок оценки: 9-10 years]
Вторичные конечные точки (7)
  • Hemodynamic Valve Performance [Срок оценки: All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year)]
  • Bioprosthetic Valve Failure [Срок оценки: All follow-ups (1-3month, 1year, 3-5 year, 6-8year 9-10 year)]
  • Bioprosthetic Valve Dysfunction [Срок оценки: All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)]
  • Patient reported outcomes [Срок оценки: 1-3month, 1+3year Follow Up compared to BL]
  • Cumulated incidence rate BVD or BVF [Срок оценки: Up to 10 years]
  • Clinical Events [Срок оценки: All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)]
  • Hemodynamic valve deterioration stage 2 and 3 (VARC-3) [Срок оценки: All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year)]

Критерии участия

Критерии включения

  • Adult patients (≥18 years)
  • Patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve
  • Patient is willing to attend the follow-up visits up to 10 years at the center

Критерии исключения

  • Lack of written informed consent
  • Emergency procedure
  • Pregnancy at time of TAVI

Critieria for long-term observation (1y-10y):

  • Technical success at exit from procedure room (VARC-3):
  • Freedom from mortality
  • Successful access, delivery of the device, and retrieval of the delivery system
  • Correct positioning of a single prosthetic heart valve into the proper anatomical location
  • Freedom from surgery or intervention related to the device (excluding permanent pacemaker or PTA and stenting without major bleeding) or to a major vascular or access related, or cardiac structural complication
  • Absence of the following severe procedural and in-hospital complications (VARC-3 definitions):
  • All stroke
  • Bleeding type 3-4
  • Myocardial infarction
  • Need for a second valve
  • Valve embolization
  • Coronary obstruction
  • Annular rupture

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

Германия · 1 центр
  • Heart and Diabetes Center North Rhine-Westphalia — Bad Oeynhausen

Идентификаторы

NCT: NCT06953206 · RESOUND-EU Registry

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗