Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)

Starting soon · Not applicable

Conditions studied: Aortic Stenosis, Severe, Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT07738575

Run by

Hospital Clinic of Barcelona

People needed

764

Starts

2026-09-01

Expected to finish

2029-06-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Institut Universitaire de cardiologie et de pneumologie de Quebec — Québec, Quebec, Canada
• Hospital Clínic de Barcelona — Barcelona, Spain
• Hospital Universitario 12 de Octubre — Madrid, Spain

Full record on ClinicalTrials.gov

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