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Heart valve fix without the hospital stay? trial tests Same-Day discharge

NCT ID NCT07738575

Disease control Sponsor: Hospital Clinic of Barcelona Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial asks whether people with severe aortic stenosis can safely go home the same day after a minimally invasive heart valve replacement (TAVI) instead of staying in the hospital. About 764 patients who are stable six hours after the procedure will be randomly assigned to either same-day discharge or standard care. The study will compare safety outcomes like death, bleeding, stroke, and readmission within 30 days, as well as quality of life and costs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Same-day discharge strategy versus standard hospital discharge after transfemoral TAVI with self-expanding valves
What this could lead to
If same-day discharge proves safe, it could shorten hospital stays and speed recovery for many TAVI patients, reducing healthcare costs.
What could go wrong
The trial is randomized but not blinded, and same-day discharge may carry risks like delayed complications. Results depend on careful patient selection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 764 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis Aortic stenosis, severe

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Clínic de Barcelona

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Institut Universitaire de cardiologie et de pneumologie de Quebec

    Québec, Quebec, G1Y 3K4, Canada

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