The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,250
- 试验地点
- 160
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis.
Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
详细描述
This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance.
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
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years of age or older at time of randomization
- •Moderate aortic stenosis
- •Subject has symptoms or evidence of cardiac damage/dysfunction
- •The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
排除标准
- •Native aortic annulus size unsuitable for the THV
- •Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system
- •Aortic valve is unicuspid or non-calcified
- •Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification
- •Pre-existing mechanical or bioprosthetic aortic valve
- •Severe aortic regurgitation
- •Prior balloon aortic valvuloplasty to treat severe AS
- •LVEF < 20%
- •Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR
- •Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
- •Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: 2 years
Non-hierarchical composite of death, and heart failure hospitalization or event
Primary Safety Endpoint
时间窗: 30 days
Non-hierarchical composite of death, stroke, life threatening or fatal bleeding, acute kidney injury stage 4, hospitalization due to device- or procedure-related complication, and valve dysfunction requiring reintervention
次要结局
- Left ventricle (LV) mass index(2 years)
- Diastolic dysfunction ≥ Grade 2(2 years)
- Death, stroke, or heart failure hospitalization(2 years)
- Alive and Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement ≥10 points from baseline sustained through 2 years(2 years)
- Heart failure hospitalization(2 years)
- Left ventricle (LV) mass index(2 years)
- Diastolic dysfunction ≥ Grade 2(2 years)