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Can a new heart valve keep future artery access open?

NCT ID NCT07813273

Knowledge-focused Sponsor: Yonsei 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are studying whether the Evolut FX Plus replacement heart valve allows doctors to reach the coronary arteries after a TAVI procedure. The trial enrolls about 122 people aged 65 and older with severe aortic stenosis. Right after the valve is implanted, doctors try to thread a catheter into the left and right coronary arteries through the valve's enlarged frame cells. CT scans months later map how the valve sits relative to the arteries.

What this could mean

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

Active substance
Evolut FX Plus transcatheter heart valve, a replacement aortic valve with enlarged frame cells
What this could lead to
If the valve's large frame cells keep coronary arteries reachable, doctors could more easily perform future heart procedures in people who receive this valve.
What could go wrong
This is a single-arm registry with about 122 patients, so it cannot prove the valve works better than others. Coronary access may still fail in some patients, and CT scans and contrast dye carry their own small risks.

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.

Participants

About 122 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

Mar 2029

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.

Who is studied

Patients with severe aortic stenosis undergoing TAVI with the Evolut FX Plus transcatheter heart valve.

Ages

65 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: 1. Patients with severe aortic stenosis undergoing TAVI with the Evolut FX Plus transcatheter heart valve. 2. Age ≥65 years. 3. Ability and willingness to provide written informed consent for participation in the study. Exclusion Criteria: 1. Inability to undergo contrast-enhanced cardiac CT before TAVI. 2. Anomalous origin of a coronary artery. 3. Bicuspid aortic valve. 4. Previous surgical or transcatheter aortic valve replacement. 5. Cardiogenic shock or hemodynamic instability. 6. Chronic kidney disease stage 3b, 4, or 5, defined as estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m². 7. Thrombocytopenia (platelet count \<100,000/μL) or an increased bleeding risk precluding antiplatelet or anticoagulant therapy. 8. Allergy or hypersensitivity to aspirin or clopidogrel precluding antiplatelet therapy in patients without an indication for oral anticoagulation.

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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 stenosis

How to take part

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

  1. 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 ↗

  2. 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.

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