HOspitalized Versus saME Day Discharge Transcatheter Aortic Valve Implantation (TAVI) With Self-expanding Valves. A Randomized Clinical Trial: The HOME-TAVI Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 764
- 试验地点
- 3
- 主要终点
- Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission
研究概览
简要总结
Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk. Advances in device technology and procedural techniques have enabled minimalist approaches and shorter hospital stays. Preliminary observational studies suggest that same-day discharge after TAVI may be feasible and safe in carefully selected patients, but randomized evidence remains limited, particularly in patients treated with self-expanding valves. The HOME-TAVI trial is a prospective, multicenter, international, randomized controlled trial designed to evaluate whether a same-day discharge strategy is non-inferior to standard hospital discharge after successful transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ system. Eligible patients who remain clinically stable 6 hours after the procedure will be randomized in a 1:1 ratio to same-day discharge or standard-of-care discharge.
The primary endpoint is a composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission within 30 days after TAVI. Secondary objectives include assessment of quality of life, patient-reported experience measures, healthcare resource utilization, and cost-effectiveness.
详细描述
Transcatheter aortic valve implantation (TAVI) has undergone substantial technological and procedural advances, leading to improved procedural safety, widespread adoption of minimalist approaches, and progressive reductions in hospital length of stay. As TAVI expands to lower-risk populations and procedure volumes continue to increase, optimizing post-procedural care pathways has become increasingly important to improve healthcare efficiency while maintaining patient safety.
Same-day discharge has emerged as a potential strategy to reduce healthcare resource utilization, improve patient satisfaction, and lower healthcare costs. Although observational studies have demonstrated the feasibility of same-day discharge in selected patients, robust randomized evidence remains scarce, especially for patients treated with self-expanding transcatheter heart valves.
The HOME-TAVI trial is a prospective, multicenter, international, randomized, controlled, open-label study evaluating a same-day discharge strategy compared with standard hospital discharge in patients undergoing elective transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ transcatheter heart valve system.
Following a successful TAVI procedure and confirmation of clinical stability 6 hours after the intervention, eligible patients will be randomized in a 1:1 ratio to same-day discharge or standard-of-care discharge. Participants will undergo follow-up assessments at 7 days, 30 days, and 1 year.
The primary objective is to demonstrate that same-day discharge is non-inferior to standard discharge with respect to a composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission within 30 days after TAVI. Secondary objectives include evaluation of quality of life, patient-reported experience measures, healthcare resource utilization, quality-adjusted life years, and health economic outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This study is open-label with respect to patients and treating providers. However, to minimize bias, statistical analyses will be conducted by a statistician blinded to group allocation whenever feasible.
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
- •Adults (≥18 years of age)
- •Severe symptomatic aortic stenosis scheduled for elective transfemoral TAVI
- •Treatment with the Medtronic Evolut PRO+, Evolut FX, Evolut FX+, or subsequent iterations
- •Successful TAVI procedure according to VARC-3 technical success criteria
- •Clinical stability 6 hours after TAVI
- •Written informed consent obtained before study participation
排除标准
- •Inability to ambulate independently at baseline
- •Hemodynamic or clinical instability before TAVI
- •Urgent or emergent TAVI procedure
- •Non-transfemoral access
- •Inadequate social support for discharge home
- •Inability to understand or comply with post-discharge instructions
- •Baseline right bundle branch block or high-grade atrioventricular block
- •Baseline left ventricular ejection fraction <20%
- •Severe chronic kidney disease (estimated glomerular filtration rate : eGFR <30 mL/min/1.73 m² or dialysis).
- •Type 2-4 bleeding within 6 hours after TAVI
- •New-onset left bundle branch block or high-grade atrioventricular block within 6 hours after TAVI, unless a permanent pacemaker has already been implanted
- •New-onset atrial fibrillation within 6 hours after TAVI
- •Persistent hemodynamic instability within 6 hours after TAVI
结局指标
主要结局
Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission
时间窗: from randomization (6 hours after TAVI) through 30 days after TAVI
Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission, defined according to Valve Academic Research Consortium-3 (VARC-3) criteria
次要结局
- Change in health-related quality of life assessed using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12)(Baseline and 30 days)
- Change in health-related quality of life assessed using the EuroQol-5 Dimensions 5 Levels (EQ-5D-5L)(Baseline and 30 days)
- Readiness for Hospital Discharge(Pre-discharge)
- Post-discharge care delivery satisfaction(7 days)
- Quality-adjusted life years (QALYs)(1 year)
- All-cause mortality(7 days and 30 days)
- Type 2-4 bleeding(7 days and 30 days)
- Major vascular complications(7 days and 30 days)
- Stroke(7 days and 30 days)
- Cardiovascular hospital readmission(7 days and 30 days)
- Non-cardiovascular hospital readmission(7 days and 30 days)
- Permanent pacemaker implantation(7 days and 30 days)
- Acute kidney injury (stage 2-4)(7 days and 30 days)
- New-onset heart failure(7 days and 30 days)
- Hospital length of stay(30 days)
- Total intensive care unit (ICU) days(30 days)
- Total number of hospital bed-days(30 days)
- Cost-utility analysis(1 year)
- Incremental cost-effectiveness ratio (ICER)(1 year)
- Budget impact analysis(1 year)