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

Condition(s) studied

Investigational drug(s) / intervention(s)

Same-Day Discharge Strategy: Participants are discharged on the same day following successful transfemoral TAVI after confirmation of clinical stability 6 hours after the procedure. The discharge pathway includes standardized clinical assessment, patient and caregiver education, pre-discharge transthoracic echocardiography and blood testing, and a follow-up telephone assessment on the day after discharge.

Standard-of-Care Discharge Strategy: Participants receive routine post-procedural inpatient care following successful transfemoral TAVI and are discharged according to standard clinical practice (next-day or later discharge), with follow-up assessments performed according to the study protocol.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission — 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

Trial sites (3)

Other trials for the same condition