Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI) (NCT07738575) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)
Canada, Spain764 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission
Timeframe: from randomization (6 hours after TAVI) through 30 days after TAVI