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Head-to-Head: which new heart valve is best for aortic stenosis?

NCT ID NCT07545369

Disease control Sponsor: Assiut University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial compares two latest-generation heart valves (SAPIEN 3 Ultra Resilia and Evolut FX) in 200 patients with severe aortic stenosis. Participants will be randomly assigned to receive one valve during a standard procedure and followed for one year. The goal is to see which valve works better and has fewer complications.

What this could mean

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

Active substance
SAPIEN 3 Ultra Resilia and Evolut FX transcatheter aortic valves
What this could lead to
If successful, this could show which valve type works better for patients with severe aortic stenosis, helping doctors choose the best option.
What could go wrong
This is a small, early-stage trial with only 200 participants, so results may not apply to all patients. Both valves are already approved, so no major breakthrough is expected.

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 200 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

Dec 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: * Severe aortic stenosis defined as aortic valve area (AVA) ≤1.0 cm², mean transvalvular gradient ≥40 mmHg, or peak transvalvular velocity ≥4.0 m/s * Symptomatic with New York Heart Association (NYHA) functional class II, III, or IV * Heart team consensus that transcatheter aortic valve implantation (TAVI) is the appropriate treatment strategy * Anatomically suitable for both valve types (SAPIEN 3 Ultra Resilia and Evolut FX) as determined by pre-procedural computed tomography (CT) imaging * Age ≥18 years * Able and willing to provide written informed consent * Able and willing to comply with all scheduled follow-up visits and assessments Exclusion Criteria: * Bicuspid aortic valve morphology * Severe mitral regurgitation or severe tricuspid regurgitation requiring intervention * Prior surgical or transcatheter aortic valve replacement * Active infective endocarditis * Contraindication to dual antiplatelet therapy or anticoagulation * Estimated life expectancy less than 1 year due to non-cardiac comorbidities * Pregnancy or breastfeeding

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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.

Severe aortic valve stenosis

How to take part

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

  1. The places running it

    1 site. 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

  • Assiut University Heart Hospital

    Asyut, Assiut Governorate, 71515, Egypt

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