Which heart valve works best for small aortic openings? a Head-to-Head trial

NCT ID NCT04372381

Terminated Disease control Sponsor: University of Arizona Source: ClinicalTrials.gov ↗

First seen Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial compares two types of transcatheter heart valves—one designed to sit above the natural valve opening (supra-annular) and one that sits within it (annular)—in people with severe aortic stenosis and a small aortic annulus (≤23 mm). The goal is to see which valve leads to fewer complications like mismatch or leakage. Participants are randomly assigned to receive either the Medtronic Evolut Pro or the Edwards Sapien Ultra 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 replacement using either a supra-annular valve (Medtronic Evolut Pro) or an annular valve (Edwards Sapien Ultra)
What this could lead to: If one valve type proves superior, it could guide surgeons toward better outcomes for patients with small aortic annuli.
What could go wrong: This is a relatively small, early-stage comparison; results may not apply to all patients, and both valves carry risks like leakage or mismatch.

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 stenosis

As listed by the trial registrant

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

AORTIC VALVE STENOSIS IMPLANTATION, HEART VALVE PROSTHESIS

Contacts and locations

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Locations

Banner - University Medical Center, Phoenix campus

Phoenix, Arizona, 85006, United States
Delray Medical Center

Delray Beach, Florida, 33484, United States
Tucson Medical Center

Tucson, Arizona, 85712, United States

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