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Набор скоро начнётся NCT05941455

A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve

Без фазы С лечением Aortic Valve Disease Cardiovascular Diseases

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: Venus-Neo Surgical Aortic Valve.
Кому может быть актуально
Состояния в реестре: Aortic Valve Disease, Cardiovascular Diseases. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.

Подробное описание

This is a prospective, multicenter, non-randomized interventional study to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve. 155 subjects are estimated to be enrolled in this study. Total enrollment period for this trial is estimated to be 1 year. Follow-up duration is estimated to be 5 years. Overall duration of the trial is estimated to be 6 years. The trial begins with the enrollment of the first subject and ends after the last subject is exited from the trial after completing the last follow-up visit at approximately 5 years, all subjects are fully monitored, all outstanding data queries are resolved.

Вмешательства

  • Устройство Venus-Neo Surgical Aortic Valve
    Implant of a Venus-Neo Surgical Aortic Valve

Первичные конечные точки

  • primary composite safety endpoint [Срок оценки: 1 year]
Вторичные конечные точки (2)
  • secondary composite safety endpoint [Срок оценки: 2 through 5 Years]
  • Occurrence of each of the following adverse events [Срок оценки: baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Patients who are clinically indicated for aortic valve replacement
  • Patients who are willing and able to participate in the follow-up requirements, and provide written informed consent

Критерии исключения

  • Previous surgical or/and transcatheter cardiac valve replacement at any site
  • Previous open-heart surgical valve repair at any site
  • Any percutaneous cardiovascular intervention (excluding diagnostic percutaneous coronary artery intervention), cardiovascular surgery, carotid surgery within 30 days
  • Untreated mitral, tricuspid, or pulmonary valve diseases requiring procedural intervention
  • Untreated clinically significant coronary artery diseases requiring revascularization
  • Acute myocardial infarct within the previous 30 days
  • Severe right heart dysfunction
  • Active infection requiring antibiotic therapy including infective endocarditis
  • Hypertrophic obstructive cardiomyopathy (HOCM)
  • Severe symptomatic carotid artery stenosis
  • Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
  • Chronic kidney disease (eGFR<45 mL/min/1.73m2) or end-stage renal disease requiring chronic dialysis
  • Hematologic disorders: Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), thrombocytopenia (Plt< 50,000 cell/mL), or any known blood clotting disorder, deemed clinically significant after consultation with Hematooncology specialists
  • Severe chronic lung disease
  • Previous organ transplant or currently an organ transplant candidate Anatomical
  • LVEF < 20%
  • Left ventricular end diastolic diameter (LVEDD) >70mm
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  • Native aortic valve geometry and size unfavorable for study bioprosthetic valve General
  • Hemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance
  • Urgent, emergency or salvage surgeries
  • Known intolerance for periprocedural/post-procedural anticoagulation or antiplatelet therapy leading to be unable to undergo index procedure per physicians' judgement
  • Life expectancy ≤ 1 year due to non-cardiac reasons
  • Planned relevant concomitant procedure within 30 days post index procedure
  • Current or recent participation (within 6 weeks prior to index procedure) in another drug or device trial
  • Pregnant, breastfeeding or intend to become pregnant within 1 year
  • Currently incarcerated or unable to give voluntary informed consent

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

Германия · 1 центр
  • Deutsches Herzzentrum Berlin-Charité — Berlin

Идентификаторы

NCT: NCT05941455 · VSAF-23-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗