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

N/ANot Yet RecruitingNCT07738575

Hospital Clinic of Barcelona764 enrolled

Overview

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.

Transcatheter aortic valve implantation (TAVI) has undergone substantial technological and procedural advances, leading to improved procedural safety, widespread adoption of minimalist approaches, and progressive reductions in hospital length of stay. As TAVI expands to lower-risk populations and procedure volumes continue to increase, optimizing post-procedural care pathways has become increasingly important to improve healthcare efficiency while maintaining patient safety. Same-day discharge has emerged as a potential strategy to reduce healthcare resource utilization, improve patient satisfaction, and lower healthcare costs. Although observational studies have demonstrated the feasibility of same-day discharge in selected patients, robust randomized evidence remains scarce, especially for patients treated with self-expanding transcatheter heart valves. The HOME-TAVI trial is a prospective, multicenter, international, randomized, controlled, open-label study evaluating a same-day discharge strategy compared with standard hospital discharge in patients undergoing elective transfemoral TAVI with the Medtronic Evolut PRO+/FX/FX+ transcatheter heart valve system. Following a successful TAVI procedure and confirmation of clinical stability 6 hours after the intervention, eligible patients will be randomized in a 1:1 ratio to same-day discharge or standard-of-care discharge. Participants will undergo follow-up assessments at 7 days, 30 days, and 1 year. The primary objective is to demonstrate that same-day discharge is non-inferior to standard discharge with respect to a composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission within 30 days after TAVI. Secondary objectives include evaluation of quality of life, patient-reported experience measures, healthcare resource utilization, quality-adjusted life years, and health economic outcomes.

Interventions

Same-Day Discharge StrategyOTHER

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 StrategyOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission, defined according to Valve Academic Research Consortium-3 (VARC-3) criteria

Time frame: from randomization (6 hours after TAVI) through 30 days after TAVI

Secondary Outcomes

Change in health-related quality of life assessed using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12)

Change in health-related quality of life measured using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). The KCCQ-12 is a disease-specific questionnaire assessing symptoms, physical limitations, social limitations, and quality of life in patients with heart disease. Scores range from 0 to 100, with higher scores indicating better health status and quality of life.

Time frame: Baseline and 30 days

Change in health-related quality of life assessed using the EuroQol-5 Dimensions 5 Levels (EQ-5D-5L)

Change in health-related quality of life measured using the EuroQol-5 Dimensions 5 Levels (EQ-5D-5L) questionnaire. The EQ-5D-5L descriptive system assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five response levels. Responses are converted into an EQ-5D-5L index value, with higher values indicating better health status. (If you are reporting the EQ Visual Analogue Scale instead of the index score, the description should instead state that the EQ VAS ranges from 0 to 100, with higher scores indicating better perceived health.)

Time frame: Baseline and 30 days

Readiness for Hospital Discharge

Patient-reported readiness for hospital discharge assessed using the Readiness for Hospital Discharge Scale (RHDS) before discharge. The RHDS score ranges from 0 to 10, with higher scores indicating greater readiness for hospital discharge.

Time frame: Pre-discharge

Post-discharge care delivery satisfaction

Patient-reported satisfaction with post-discharge care assessed using the Post-Discharge Care Delivery Satisfaction (PDCDS) questionnaire at 7 days after discharge. The PDCDS score ranges from \[minimum\] to \[maximum\], with higher scores indicating greater satisfaction with post-discharge care.

Time frame: 7 days

Quality-adjusted life years (QALYs)

Quality-adjusted life years (QALYs) calculated by combining survival duration and health utility values derived from the EuroQol-5 Dimensions 5 Levels (EQ-5D-5L) questionnaire into a single outcome measure.

Time frame: 1 year

All-cause mortality

Incidence of all-cause mortality defined according to Valve Academic Research Consortium 3 (VARC-3) criteria.