Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)
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- How often do I need to come in, and for how long each time?
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Contact the study team: see the registry record → Contacts and Locations
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- Who runs it
- Hospital Clinic of Barcelona
- Trial code
- NCT07738575
- Record updated
- 31 July 2026
- Original description
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.Read full original descriptionShow less
HOspitalized Versus saME Day Discharge Transcatheter Aortic Valve Implantation (TAVI) With Self-expanding Valves. A Randomized Clinical Trial: The HOME-TAVI Trial
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.
Inclusion: 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.
Exclusion: Type 2-4 bleeding within 6 hours after TAVI; Baseline left ventricular ejection fraction <20%; Severe chronic kidney disease (estimated glomerular filtration rate : eGFR <30 mL/min/1.73 m² or dialysis); 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; 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.