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

MI-összefoglaló

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The trial is looking for adults with severe aortic stenosis (a narrowed heart valve) who had a planned TAVI valve replacement through the groin. It compares going home the same day with the usual hospital stay.

Életkor

18 years and older

Nem

All sexes

A betegség stádiuma

Severe aortic stenosis that causes symptoms, with a planned (not urgent) TAVI through the groin artery (transfemoral). The TAVI must have worked well by VARC-3 criteria, and you must be stable 6 hours after it.

Korábbi kezelés

TAVI with the Medtronic Evolut PRO+, Evolut FX, Evolut FX+, or newer versions.

A részvétel fő kizáró okai

• Not able to walk on your own before the procedure
• Urgent or emergency TAVI, TAVI not through the groin, or unstable before TAVI
• Heart rhythm problems (right bundle branch block or high-grade atrioventricular block) before TAVI, or new rhythm problems or atrial fibrillation within 6 hours after TAVI
• Heart pumping strength (ejection fraction) below 20%, or severe kidney disease (eGFR <30 mL/min/1.73 m² or dialysis)
• Type 2-4 bleeding within 6 hours after TAVI, or not enough support at home

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 2 csoportja

• Same-Day DischargeA vizsgált kezelés

  Participants randomized to the experimental arm will undergo a predefined same-day discharge pathway following successful transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ system. Patients who remain clinically stable 6 hours after the procedure will be discharged on the same day after completion of the required clinical assessments and discharge education. A follow-up telephone assessment will be performed on the day after the procedure.

  Kezelés: Same-Day Discharge Strategy

• Standard-of-Care DischargeMár használt kezelés, összehasonlításként

  Participants randomized to the control arm will receive standard inpatient post-procedural care and will be discharged according to local standard clinical practice (next-day or later discharge).

  Kezelés: Standard-of-Care Discharge Strategy