COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Официальное название

COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV

Обзор

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Вмешательства

• Устройство SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
  SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
• Устройство SAPIEN 3 THV
  SAPIEN 3 THV in the pulmonic position
• Устройство SAPIEN 3 Ultra RESILIA THV
  SAPIEN 3 Ultra RESILIA THV in the pulmonic position

Первичные конечные точки

• THV dysfunction [Срок оценки: 1 year]

Вторичные конечные точки (10)

• Device Success [Срок оценки: Discharge, expected to be within 1-5 days post-procedure]
• Mean RVOT gradient [Срок оценки: 6 months]
• Paravalvular and total PR [Срок оценки: 6 months]
• RVOT reintervention [Срок оценки: 6 months]
• Coronary artery compression requiring intervention [Срок оценки: 30 days]
• Major vascular complications [Срок оценки: 30 days]
• Life-threatening or disabling bleeding [Срок оценки: 30 days]
• THV frame fracture [Срок оценки: 6 months]
• Device-related endocarditis [Срок оценки: 1 year]
• Death (all-cause, procedural and device-related) [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Weight ≥ 20 kg (44 lbs.)
• Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use
• Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
• The subject/subject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Критерии исключения

• Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
• History of or active endocarditis (active treatment with antibiotics) within the past 180 days
• Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
• Inappropriate anatomy for femoral introduction and delivery of the study valve
• Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
• Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
• Interventional/surgical procedures within 30 days prior to the TPVI procedure.
• Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.
• History of or current intravenous drug use
• Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
• Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
• Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated
• Participating in another investigational drug or device study that has not reached its primary endpoint.
• Female who is lactating or pregnant

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 · 27 центров

• University of Alabama at Birmingham — Birmingham
• Arkansas Children's Hospital — Little Rock
• University of California, Los Angeles — Los Angeles
• University of California,, San Francisco (UCSF) — San Francisco
• Childrens Hospital of Colorado — Aurora
• Emory University/Children's Healthcare of Atlanta — Atlanta
• University of Kentucky — Lexington
• Massachusetts General Hospital — Boston
• … и ещё 19 центров

Публикации

• Lim DS, Kim D, Aboulhosn J, Levi D, Fleming G, Hainstock M, Sommer R, Torres AJ, Zhao Y, Shirali G, Babaliaros V. Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial). Am J Cardiol. 2023 Mar 1;190:102-109. doi: 10.1016/j.amjcard.2022.12.010. Epub 2023 Jan 4. PMID 36608435
• Hainstock MR, Fleming G, Kim D, Aboulhosn J, Levi D, Krasuski R, Sommer R, Torres AJ, Gray R, Kereiakes D, Leventhal A, Gillespie M, Szeto W, Zajarias A, Shahanavaz S, Steinberg ZL, Jones TK, Mahadevan VS, Moore P, Elmariah S, Shirali G, Li W, Babaliaros V, Lim DS; COMPASSION 3 Trial Executive Committee and Study Investigators. Five-Year Outcomes for Patients With RVOT Dysfunction Treated With the PMID 41884901

Идентификаторы

NCT: NCT02744677 · 2015-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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