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New imaging method could improve heart surgery outcomes for aortic stenosis patients

NCT ID NCT07469371

Disease control Sponsor: Yan'an Affiliated Hospital of Kunming Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a special heart scan called CT-FFR can help doctors make better decisions about treating blocked arteries before valve replacement surgery. 300 patients with severe aortic stenosis will be randomly assigned to have their treatment guided by either standard scans or CT-FFR. The goal is to see if CT-FFR reduces major heart problems like heart attacks or death within one year.

What this could mean

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

Active substance
CT-derived fractional flow reserve (CT-FFR) imaging test
What this could lead to
If successful, this could show that using CT-FFR to guide treatment decisions before valve replacement reduces the risk of heart attacks, heart failure, or death in patients with severe aortic stenosis.
What could go wrong
This is a single-center trial with 300 participants, so results may not apply to all patients. The benefit of CT-FFR over standard imaging is unproven, and the follow-up is only one year.

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 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

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: 1. Age \>18 years. 2. Severe aortic stenosis confirmed by echocardiography, defined as peak aortic jet velocity (Vmax) ≥4.0 m/s, mean transvalvular gradient ≥40 mmHg, or aortic valve area (AVA) ≤1.0 cm² \[or indexed aortic valve area (AVAi) ≤0.6 cm²/m²\]. 3. New York Heart Association (NYHA) functional class II or higher. 4. Eligible for both transfemoral transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). 5. Undergoing preoperative coronary computed tomography angiography (CCTA). 6. Willing to participate in the study and able to provide written informed consent. Exclusion Criteria: 1. Allergy to prosthetic valve materials or iodinated contrast agents. 2. Contraindication or allergic reaction to anticoagulants or antiplatelet agents, or inability to tolerate required anticoagulant or antiplatelet therapy. 3. Active infective endocarditis or any other active infection. 4. Severe vascular disease precluding safe implantation of a prosthetic valve. 5. Ascending aortic diameter ≥50 mm. 6. Prior prosthetic valve implantation in any cardiac position or prior coronary artery bypass grafting (CABG). 7. Preoperative imaging confirming aortic root anatomy unsuitable for transcatheter aortic valve implantation. 8. Intracardiac mass, left ventricular or left atrial thrombus, or vegetation confirmed by preoperative echocardiography. 9. Acute myocardial infarction within 30 days before surgery. 10. Clinically diagnosed stroke or transient ischemic attack within 3 months before surgery. 11. Bleeding or coagulation disorders within 3 months before surgery that required hospitalization or blood transfusion or were otherwise clinically significant and would preclude the antiplatelet therapy required in this study.

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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 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

  • Yan'an Hospital Affiliated to Kunming Medical University

    RECRUITING

    Kunming, Yunnan, 650050, China

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