Идёт набор NCT03003299

PARTNER 3 Trial - Aortic Valve-in-Valve

Без фазы С лечением Aortic Stenosis Aortic Stenosis, Severe

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: Edwards SAPIEN 3/SAPIEN 3 Ultra THV.
Кому может быть актуально: Состояния в реестре: Aortic Stenosis, Aortic Stenosis, Severe. 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: США, Канада
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

A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve

Обзор

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Подробное описание

This is a prospective, single-arm, multicenter study.

Вмешательства

Устройство Edwards SAPIEN 3/SAPIEN 3 Ultra THV
Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.

Первичные конечные точки

Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke [Срок оценки: 1 year]

Вторичные конечные точки (5)

Mean gradient [Срок оценки: 30 days]
Peak gradient [Срок оценки: 30 days]
Kansas City Cardiomyopathy Questionnaire (KCCQ) [Срок оценки: 30 days]
New York Heart Association (NYHA) Classification [Срок оценки: 30 days]
Six-Minute Walk Test (6MWT) [Срок оценки: 30 days]

Критерии участия

Критерии включения

Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
NYHA Functional Class ≥ II.
Heart Team agrees the patient is low to intermediate risk.
Heart Team agrees valve implantation will likely benefit the patient.
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Критерии исключения

Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
Severe regurgitation (> 3+) or stenosis of any other valve
Failing valve has moderate or severe paravalvular regurgitation
Failing valve is unstable, rocking, or not structurally intact
Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
Increased risk of embolization of THV
Known bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve
Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
Anatomical characteristics that would preclude safe access to the apex (Transapical)
Evidence of an acute myocardial infarction ≤ 30 days before enrollment
Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.
Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation
Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
Untreated clinically significant coronary artery disease requiring revascularization
Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment
Emergency interventional/surgical procedures within 30 days prior to the procedure
Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure
Hypertrophic cardiomyopathy with obstruction
LVEF < 30%
Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
Stroke or transient ischemic attack within 90 days of enrollment
Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
Renal insufficiency and/or renal replacement therapy at the time of screening
Active bacterial endocarditis within 180 days of the procedure
Patient refuses blood products
Estimated life expectancy < 24 months
Positive urine or serum pregnancy test in female subjects of childbearing potential
Currently participating in an investigational drug or another device study