Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Heart valve showdown: which replacement works best for failed surgical valves?

NCT ID NCT06049654

Disease control Sponsor: Fundación EPIC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two different devices (Allegra and Sapien) used to replace a failing surgically implanted aortic heart valve without open-heart surgery. About 104 adults with a deteriorated biological aortic valve will be randomly assigned to get one of the two devices. The main goal is to see which device provides better blood flow through the new valve.

What this could mean

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

Active substance
transcatheter aortic valve implantation device (Allegra or Sapien)
What this could lead to
If successful, this could show which device is better for replacing a worn-out surgical aortic valve, improving heart function and symptoms.
What could go wrong
This is a relatively small trial (104 people) and only compares two specific devices. Results may not apply to all patients or other valves.

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 104 people

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

Started

Feb 2024

Expected to finish

Nov 2027

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: Patients meeting ALL the following criteria will be included: * Patients aged ≥ 18 years. * Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area \< 1.0 cm2) and/or severe valve regurgitation. * The patient has cardiac symptoms and/or deterioration of left ventricular ejection fraction attributable to the aortic valve disease. * Heart team decision of VIV procedure. * Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year. Exclusion Criteria: Patients meeting, at least, 1 of the following criteria will be excluded: * Patients who openly express their refusal to participate in the study. * Female patients in gestational age. * Presence or suspicious of biological aortic valve thrombosis. * Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated. * Ongoing sepsis and/or suspicious or diagnosis of endocarditis. * Patients whose life expectancy is \< 1 year due to non-cardiac comorbid conditions. * Medical, social, or psychological conditions that preclude the subject from appropriate consent or adherence to the protocol required follow-up exams. * True inner diameter of the prosthetic valve \> 27 mm. * Transfemoral access inadequate to accommodate an 18F sheath. * Patients included in other clinical trials (excluding registries).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Aortic valve stenosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

aortic valve insufficiency aortic valve stenosis

As listed by the trial registrant

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

Aortic valve stenosis Structural valve deterioration

How to take part

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

  1. The places running it

    11 sites in 3 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

  • Azienda Ospedaliera di Perugia

    RECRUITING

    Perugia, Italy

  • Azienda Ospedaliero- Universitaria di Alessandria

    RECRUITING

    Alessandria, Italy

  • Freeman Hospital

    RECRUITING

    Newcastle, United Kingdom

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Clínico Universitario de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hospital Universitari I Politècnic de La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitari de Bellvitge

    RECRUITING

    L'Hospitalet de Llobregat, 08907, Spain

  • Hospital Universitario Puerta De Hierro

    RECRUITING

    Majadahonda, 28222, Spain

  • Hospital Universitario de La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Manchester University NHS Foundation Trust

    RECRUITING

    Manchester, United Kingdom

  • Morriston Hospital, Swansea

    RECRUITING

    Swansea, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.