ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral

Официальное название

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve - Mitral

Обзор

This study will establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring.

Подробное описание

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

Вмешательства

• Устройство SAPIEN X4 THV
  Implantation of the SAPIEN X4 valve

Первичные конечные точки

• Non-hierarchical composite of death and stroke at 1 year [Срок оценки: 1 year]

Вторичные конечные точки (4)

• Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline [Срок оценки: 30 days]
• Kansas City Cardiomyopathy Questionnaire (KCCQ) score compared to baseline [Срок оценки: 1 year]
• New York Heart Association (NYHA) functional class compared to baseline [Срок оценки: 30 days]
• New York Heart Association (NYHA) functional class compared to baseline [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
• Bioprosthetic surgical valve or native mitral annulus size suitable for SAPIEN X4 THV
• NYHA functional class ≥ II
• Heart Team agrees the subject is at high or greater surgical risk
• The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

Критерии исключения

• Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
• Interatrial septum or left atrium not suitable for transcatheter transseptal access
• Failing valve has mild or greater paravalvular regurgitation
• Failing valve is unstable, rocking, or not structurally intact
• Annuloplasty ring dehiscence
• Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient > 10 mmHg at the end of the index procedure for implantation of the original valve
• Annuloplasty ring type not favorable for THV implantation
• Increased risk of THV embolization
• Anatomical characteristics that would increase risk of left ventricular outflow tract (LVOT) obstruction
• Surgical or transcatheter aortic valve extending into LVOT that may impinge on the mitral implant
• Severe right ventricle (RV) dysfunction
• Severe regurgitation or stenosis of any other valve
• Need for aortic, tricuspid, or pulmonic valve intervention within the next 12 months
• Left ventricular ejection fraction < 20%
• Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
• Myocardial infarction within 30 days prior to the study procedure
• Hypertrophic cardiomyopathy with subvalvular obstruction
• Subjects with planned concomitant ablation for atrial fibrillation
• Clinically significant coronary artery disease requiring revascularization
• Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
• Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure
• Endocarditis within 180 days prior to the study procedure
• Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
• Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
• Renal insufficiency and/or renal replacement therapy
• Leukopenia, anemia, thrombocytopenia
• Inability to tolerate or condition precluding treatment with antithrombotic therapy
• Hypercoagulable state or other condition that increases risk of thrombosis
• Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
• Subject refuses blood products
• Body mass index > 50 kg/m2
• Estimated life expectancy < 24 months
• Female who is pregnant or lactating
• Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
• Participating in another investigational drug or device study that has not reached its primary endpoint
• Subject considered to be part of a vulnerable population

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06167213 · 2021-05-Mitral

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗