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

NCT ID NCT06049654

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

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.

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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.

AORTIC VALVE STENOSIS STRUCTURAL VALVE DETERIORATION

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

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