A Prospective, Multi-centre, Single Arm, Pivotal Clinical Study to Determine the Safety and Effectiveness of Crea Aortic Valve for Use as a Replacement Aortic Heart Valve

Обзор

This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native aortic valve stenosis who are considered appropriate candidates for transcatheter valve replacement. Eligible subjects will be enrolled at multiple investigational sites and followed according to the clinical investigation plan. The study will assess procedural success, device performance, and clinical safety using predefined clinical and echocardiographic outcome measures. Subjects will undergo scheduled follow-up evaluations to assess device performance, functional status, quality of life, and the occurrence of adverse clinical events over the study period.

Подробное описание

Severe symptomatic aortic valve stenosis is a progressive disease associated with significant morbidity and mortality if left untreated. Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for appropriately selected patients with severe native aortic valve disease who are considered suitable candidates for transcatheter intervention.

This clinical investigation is designed to evaluate an investigational transcatheter aortic valve replacement system developed for the treatment of severe symptomatic native aortic valve stenosis. The study will collect clinical evidence to assess the safety and performance of the investigational device in accordance with the Clinical Investigation Plan and applicable regulatory requirements.

Вмешательства

• Устройство Investigational Transcatheter Aortic Valve Replacement System
  Investigational transcatheter bioprosthetic aortic valve replacement system intended for treatment of severe symptomatic native aortic valve stenosis.

Первичные конечные точки

• Percentage of Participants With Technical Success [Срок оценки: At completion of the index procedure (exit from procedure room)]
• Percentage of Participants With Device Success [Срок оценки: 30 days after the procedure]
• Percentage of Participants Free From Early Safety Events [Срок оценки: 30 days after the procedure]

Вторичные конечные точки (9)

• All-cause Mortality rate [Срок оценки: Through 5 years]
• Cardiovascular Mortality Rate [Срок оценки: Through 5 years]
• Percentage of Participants Experiencing Stroke [Срок оценки: Through 5 years]
• Rate of Valve- or Procedure-Related Rehospitalization [Срок оценки: Through 5 years]
• Hemodynamic Valve Performance assessed by Echocardiography [Срок оценки: Through 5 years]
• Change From Baseline in NYHA Functional Class [Срок оценки: Baseline through 5 years]
• Change From Baseline in Six-Minute Walk Test (6MWT) Distance [Срок оценки: Baseline through 5 years]
• Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Overall Summary Score [Срок оценки: Baseline through 5 years]
• Percentage of Permanent Pacemaker Implantation [Срок оценки: Through 5 years]

Критерии участия

Критерии включения

• Age 60 years or older.
• Symptomatic severe native calcific aortic valve stenosis.
• Considered appropriate for transcatheter aortic valve replacement (TAVR) by the local Heart Team.
• Considered at high surgical risk for surgical aortic valve replacement.
• Able to understand the study requirements and provide written informed consent.
• Willing and able to comply with all study procedures and follow-up visits.

Критерии исключения

• Contraindication to transcatheter aortic valve replacement or the investigational procedure.
• Active infection or endocarditis.
• Life expectancy less than one year due to non-cardiac comorbidities.
• Participation in another investigational study that could interfere with the objectives of this study.
• Any medical, anatomical, or clinical condition that, in the opinion of the investigator or Heart Team, would make study participation inappropriate or place the subject at unacceptable risk.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07734025 · CT-XXXX-CAVS-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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