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

Study acronym: HOME-TAVI
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07738575
Lead Sponsor Hospital Clinic of Barcelona
Conditions
(from sponsor)		 Aortic Stenosis, Severe, Aortic Stenosis
Related terms Aortic Valve Stenosis
Enrollment 764 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov