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NCT07738575

Overview

NCT ID: NCT07738575
Lead Sponsor: Hospital Clinic of BarcelonaOTHER
Official Title: HOspitalized Versus saME Day Discharge Transcatheter Aortic Valve Implantation (TAVI) With Self-expanding Valves. A Randomized Clinical Trial: The HOME-TAVI Trial
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Dec 31, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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 Criteria:

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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 764Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Ander Regueiro, MDContact
AREGUEIR@clinic.cat+34932275400 ext. 5519

Similar Studies

Participant Group/Arms

Same-Day DischargeExperimental

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.

Other: Same-Day Discharge Strategy

Standard-of-Care DischargeActive Comparator

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).

Other: Standard-of-Care Discharge Strategy