CoreValve Evolut Pro Prospective Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Device success:
研究概览
简要总结
The primary objective of this study is to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective observational registry.
详细描述
The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. This latest generation device features an outer wrap to improve annular sealing and reduce paravalvular leak.
In this observational study, baseline demographic and imaging characteristics, procedural details and clinical outcomes of patients undergoing transcatheter aortic valve replacement with the CoreValve Evolut PRO will be prospectively collected into a registry database. The institutional Heart Team will select patients according to standard practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic severe aortic stenosis
- •Intermediate, high or extreme surgical risk
- •The institutional Heart Team determines that transcatheter aortic valve replacement with an Evolut Pro device is appropriate
排除标准
- •Subject unable or unwilling to give informed consent
- •For subjects in the CT arm only, renal function precluding the administration of iodinated contrast for cardiac CT (eGFR < 30 ml/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 to become pregnant prior to completion of all protocol follow-up procedures
结局指标
主要结局
Device success:
时间窗: 30 days
Absence of procedural mortality Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient\<20 mm Hg or peak velocity\<3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Acute Kidney Injury Stage 2 or 3
时间窗: 30 days
AKI will be evaluated using the VARC-2 definition of Stage 2 or 3 AKI
Coronary Artery Obstruction requiring intervention
时间窗: 30 days
This will be assessed if by noting whether the patient has a re intervention
Major Vascular Complication
时间窗: 30 days
Major Vascular Complication will be evaluated using the VARC-2 definition of Major Vascular Complication
Valve - related Dysfunction
时间窗: 30 Days
Valve related dysfunction will be evaluated by determining whether the subject has a repeat procedure such as a BAV, TAVI, or SAVR
All Cause Mortality
时间窗: 30 days
all causes of death
All Stroke (disabling and non-disabling
时间窗: 30 days
Stroke will evaluated using the VARC-2 definition
Life Threatening Bleeding
时间窗: 30 Days
Life Threatening Bleeding will be evaluated using the VARC-2 definition
次要结局
- Prosthetic valve dysfunction #2(1 year)
- Prosthetic valve dysfunction(1 year)
- Prosthetic valve dysfunction #4(1 year)
- Reduction in PVL(Discharge thru to 1 year)
- Prosthetic valve dysfunction #1(1 year)
- Prosthetic valve dysfunction #3(1 year)