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

NCT ID NCT06049654

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

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