Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,032
- 试验地点
- 112
- 主要终点
- All-cause Death or Disabling Stroke to Two Years
研究概览
简要总结
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.
详细描述
The PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery.
To assure that patients with an STS score ≥ 4% have been selected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA < 0.5 cm2/m2 Qualifying echo must be within 60 days of the date of the procedure.
- •Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
- •The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
- •The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- •The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.
- •Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if randomized to control treatment.
排除标准
- •Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
- •Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
- •Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
- •Preexisting mechanical or bioprosthetic valve in any position (except NR3).
- •Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD (S3 Cohort only) is not excluded.
- •Heart team assessment of inoperability (including examining cardiac surgeon).
研究组 & 干预措施
PIIA - SAPIEN XT
PIIA is operable group
干预措施: TAVR Implantation with SAPIEN XT (Device)
Control: SAVR
SAVR (surgical aortic valve replacement) is the control arm
干预措施: SAVR Implantation (Device)
结局指标
主要结局
All-cause Death or Disabling Stroke to Two Years
时间窗: 2 Years
All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)
次要结局
- Adjusted Days Alive and Out of Hospital (DAOH) to Two Years(2 years)
- 6MWT Change From Baseline(Baseline and 2 years)
- Effective Orifice Area (EOA)(2 years)
- Total Aortic Regurgitation (AR) at 2 Years(2 years)
- NYHA Classification at 2 Years(2 years)