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Набор скоро начнётся NCT05528211

Safety and Efficacy of Emergent TAVI in Patients With Severe AS

— Наблюдательное Aortic Valve Stenosis Transcatheter Aortic Valve Implantation Emergencies

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Emergencies. Базовые параметры: Без ограничений · 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Safety and Efficacy of Emergent Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Aortic Valve Stenosis (AS): a Single-center, Prospective, Observational Cohort Study.

Обзор

This is a single-centre, prospective, observational cohort study focusing on of patients suffering severe aortic valve stenosis (AS) undergoing emergent transcatheter aortic valve implantation (TAVI). AS patients undergoing emergent TAVI always have complicated clinical situations. Therefore, the aims of the study are to collect the incidence and outcomes of emergent TAVI in patients with severe symptomatic AS, to assess the safety and effectiveness of emergency TAVI system for severe AS, and to describe a more practical evidence of emergency TAVI system in severe AS patients.

Первичные конечные точки

  • All-cause mortality [Срок оценки: 12 months post-TAVI]
Вторичные конечные точки (8)
  • The incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) during the trial [Срок оценки: immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI]
  • Acute kidney injury [Срок оценки: immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI]
  • Permanent pacemaker implantation [Срок оценки: immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI]
  • Vascular complications (life-threatening or disabling) [Срок оценки: immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI]
  • The incidence of other TAVI complications [Срок оценки: immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI]
  • Valve function [Срок оценки: immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI]
  • Cardiac function improvement [Срок оценки: immediate, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-TAVI]
  • Device success rate [Срок оценки: immediate post-TAVI]

Критерии участия

Критерии включения

  • Every patient that diagnosed with severe aortic valve stenosis (evaluated by echocardiography: peak transaortic valve blood flow rate ≥4.0m/s, or mean transaortic valve pressure gradient ≥40mmHg (≥5.32kPa), or aortic Valve area <0.8cm2, or AVA<0.5cm2/m2);
  • Every patient that 1) required cardiopulmonary resuscitation due to cardiac arrest, or requiring external chest compressions during surgery (Salvage), 2) or has ongoing, refractory (difficult, complicated, and/or unmanageable) unrelenting cardiac compromise, with or without hemodynamic instability, and not responsive to any form of therapy except cardiac surgery (STS/ACC TVT defined "Urgent Status"), 3) or required urgent procedure during same hospitalization in order to minimize chance of further clinical deterioration (examples include, but are not limited to, worsening, sudden chest pain, heart failure, acute myocardial infarction, anatomy, intra-aortic balloon pump, unstable angina with intravenous nitroglycerin or rest angina) (STS/ACC TVT defined "Urgent Status");
  • Every patient that has been informed of the objectives of the study, agreed to participate, has signed the approved consent form, and was willing to accept all relevant examinations and clinical follow-up.

Критерии исключения

  • Anatomically, the approach or aortic root is not suitable for transcatheter aortic valve implantation (TAVI).
  • Anatomical morphology or vascular diseases affecting the device approach.
  • Left ventricular outflow tract obstruction.
  • Primary dilated cardiomyopathy.
  • The echocardiogram indicates the presence of left ventricular thrombus.
  • Cannot tolerate anticoagulation and antiplatelet therapy.
  • Are allergic or resistant to nickel titanium alloys.
  • Active infective endocarditis, or other active infections affecting the effect of TAVI.
  • Severe disabling Alzheimer's disease.
  • Life expectancy< 6 months.
  • Other conditions (examples include poor compliance of patients and families) considered by the investigator to be inappropriate for participation in this clinical trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05528211 · 20220823LCB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗