Project to Look for Early Discharge in Patients Undergoing TAVI With ACURATE - An International Multi-center Early Discharge TAVI Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 15
- 主要终点
- Primary safety endpoint
研究概览
简要总结
An international multi-center prospective observational study to address safety and feasibility of an early discharge protocol in patients with symptomatic severe aortic stenosis who are eligible for transfemoral TAVI with the Boston Scientific ACURATE Neo Aortic Bioprosthesis transcatheter heart valve.
详细描述
In this International multi-center prospective observational study, 250 patients with severe symptomatic aortic stenosis (AS) and eligibility for transfemoral TAVI with ACURATE Neo Bioprosthesis, will be pre-procedurally selected for participation in an early discharge protocol in which patients are discharged within 48 hours after uncomplicated TAVI.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for ACURATE Neo valve implantation
- •Patient agrees to follow-up duration
- •Patient is able to understand and sign written informed consent
排除标准
- •BMI > 35
- •Pregnancy
- •Moderate to severely impaired left ventricular ejection fraction (LVEF <35%)
- •Mitral regurgitation > moderate
- •Pulmonary hypertension (sPAP > 60mmHg)
- •No complex coronary artery disease
- •Untreated high degree AV-block or RBBB
- •COPD Gold > 2
- •Kidney function
- •GFR < 35ml/min
- •Inappropriate social support and/or (familial) care
- •Patient is walking aid dependent
- •TAVI strategy
- •Presence of severe peripheral artery disease
- •Transfemoral approach not possible
- •Inability to adhere to follow-up
结局指标
主要结局
Primary safety endpoint
时间窗: 30 days
Composite of all-cause mortality, any stoke, VARC type 2-4 bleeding, acute kidney injury stage 3-4, major vascular, major access related, major cardiac structural complication, moderate or severe aortic regurgitation, new permanent pacemaker implantation and valve-related dysfunction requiring repeat procedure at 30 days
Primary efficacy endpoint at 1 year
时间窗: 1 year
Composite of all-cause mortality, all stroke, re-hospitalization for procedure- or valve-related causes, KCCQ Overall Summary Score \<45 or decline from baseline \>10 points at 1 year
Primary efficacy endpoint at 30 days
时间窗: 30 days
Composite of all-cause mortality, all stroke, re-hospitalization for procedure- or valve-related causes, KCCQ Overall Summary Score \<45 or decline from baseline \>10 points at 30 days
次要结局
- Stroke(30 days and 1 year)
- Major vascular complication(30 days and 1 year)
- Acute kidney injury(30 days and 1 year)
- All-cause mortality(30 days and 1 year)
- Life threatening bleeding(30 days and 1 year)
- Coronary artery obstruction requiring intervention(30 days and 1 year)
- Valve related dysfunction requiring repeat procedure(30 days and 1 year)
- New permanent pacemaker implantation(30 days and 1 year)
- Patient reported Quality of Life(30 days and 1 year)
- Rehospitalization for valve-related symptoms or worsening congestive heart failure(30 days and 1 year)
- Categorical cost analysis(30 days)
- All-cause rehospitalization(30 days and 1 year)
- Myocardial infarction(30 days and 1 year)
- NYHA heart failure class III or IV(30 days and 1 year)
研究者
Nicolas van Mieghem
Principal Investigator
Erasmus Medical Center