COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 27
- 主要终点
- THV dysfunction
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
TPVR - Main Cohort
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
干预措施: SAPIEN 3 THV (Device)
TPVR - THV Registry
Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR.
干预措施: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV (Device)
TPVR- S3UR Registry
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
干预措施: SAPIEN 3 Ultra RESILIA THV (Device)
结局指标
主要结局
THV dysfunction
时间窗: 1 year
Defined as a non-hierarchical composite of: RVOT reintervention, Moderate or greater total pulmonary regurgitation (PR) via Transthoracic Echocardiography (TTE), Mean RVOT gradient \> 40 mmHg via TTE
次要结局
- THV frame fracture(6 months)
- Device Success(Discharge, expected to be within 1-5 days post-procedure)
- Paravalvular and total PR(6 months)
- RVOT reintervention(6 months)
- Mean RVOT gradient(6 months)
- Major vascular complications(30 days)
- Life-threatening or disabling bleeding(30 days)
- Device-related endocarditis(1 year)
- Coronary artery compression requiring intervention(30 days)
- Death (all-cause, procedural and device-related)(1 year)