ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Официальное название

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Обзор

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

Подробное описание

Prospective, single arm, multicenter study

Вмешательства

• Устройство SAPIEN X4/X4S THV
  Implantation of the SAPIEN X4/X4S valve

Первичные конечные точки

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

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
• Bioprosthetic valve 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
• Failing valve has moderate or severe paravalvular regurgitation
• Failing valve is unstable, rocking, or not structurally intact
• Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve
• Increased risk of THV embolization
• Surgical or transcatheter valve in the mitral position
• Severe mitral regurgitation (> 3+) or ≥ moderate mitral stenosis
• Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
• Left ventricular ejection fraction < 20%
• Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
• Increased risk of coronary artery obstruction after THV implantation
• 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 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

США · 33 центра

• Hoag Memorial Hospital Presbyterian — Newport Beach
• Bay Area Structural Heart at Sutter Health — San Francisco
• Kaiser San Francisco — San Francisco
• Stanford University Medical Center — Stanford
• UC Health Medical Center of the Rockies — Loveland
• Naples Community Hospital Healthcare System — Naples
• Emory University Atlanta — Atlanta
• Piedmont Heart Institute — Atlanta
• … и ещё 25 центров

Канада · 3 центра

• St. Paul's Hospital Vancouver — Vancouver
• Hamilton Health Sciences — Hamilton
• Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval — Québec

Идентификаторы

NCT: NCT05172973 · 2021-05-AVIV

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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