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NCT07738575
Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)
Conditions: Aortic Stenosis, Severe, Aortic Stenosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 764
Sponsor: Hospital Clinic of Barcelona
Location: Institut Universitaire de cardiologie et de pneumologie de Quebec Québec Quebec
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 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 \
Source: ClinicalTrials.gov (NCT07738575). StuddyBuddy aggregates publicly available trial information.