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Not Yet Recruiting 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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07738575). StuddyBuddy aggregates publicly available trial information.