Supra-Annular vs. Annular ValvEs for Small Annuli (<= 23mm)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation
研究概览
简要总结
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
详细描述
Patient prothesis mis-match (PPM) remains a clinical dilemma in transcatheter aortic valve replacement (TAVR) and has been linked to higher rates of morbidity and mortality. Supra-annular self-expanding valves have been linked to lower gradients and lower rates of patient prosthesis mismatch versus annular valves but they have not been directly compared. Patients with small annuli are particularly vulnerable to PPM, therefore, the aprior hypothesis is that implantation of supra-annular valves for small annuli may show differences in PPM rates and outcomes when compared to annular valves.
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
- •Symptomatic subjects with severe native aortic valve stenosis
- •aortic valve annulus mean diameter ≤23 mm
- •Patient meet commercial indication for transcatheter aortic valve replacement (TAVR)
- •Institutional heart team determines that TAVR is appropriate
- •Patient's anatomy is appropriate for either Medtronic Evolute or Edwards Sapien 3 Ultra
排除标准
- •Subject unable or unwilling to provide informed consent
- •Intended concurrent structural heart procedure (e.g. transcatheter mitral valve repair or replacement, left atrial appendage closure)
- •Renal function precluding the administration of iodinated contrast (eGFR < 30ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media
- •Pregnancy or intent on becoming pregnant prior to completion of all proctocol follow-up procedures
- •Patients at high risk for coronary obstruction
- •Patients with low-flow low gradient aortic valve stenosis
- •patients at high risk for annular rupture with implantation of a balloon expandable valve
研究组 & 干预措施
Supra-Annular transcatheter heart valve
Medtronic Evolut Pro Valve implantation
干预措施: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro (Device)
Annular transcatheter heart valve
Edwards Sapien 3 Ultra implantation
干预措施: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro (Device)
结局指标
主要结局
Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation
时间窗: 1 month
次要结局
- VARC-2 30-day early safety and efficacy(30 days)
- Pacemaker implantation(30 days)
- Prosthetic Valve Dysfunction(30 days and 1 year)
研究者
Marvin Eng
Associate Professor, Internal Medicine
University of Arizona