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Heart valve surgery may change how we measure artery blockages

NCT ID NCT04420325

Knowledge-focused Sponsor: Universitaire Ziekenhuizen KU Leuven 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at 116 patients with severe aortic stenosis and moderate coronary artery disease who were scheduled for valve replacement. Researchers measured blood flow in the heart arteries before, right after, and 6 months after valve replacement to see how the procedure affects standard tests for artery blockages. The goal was to improve accuracy in deciding which patients need additional artery treatment.

What this could mean

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

What this could lead to
If successful, this study could help doctors better decide which patients with aortic stenosis also need treatment for blocked heart arteries.
What could go wrong
This is an observational study, not a treatment trial. It only measures changes and does not test a new therapy, so it cannot directly improve patient outcomes.

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

116 people

The number who actually took part.

Started

Jun 2020

Finished

Oct 2024

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 undergoing routine cardiac catheterization during preparation for TAVI or SAVR, who are found to have coronary artery disease, will be approached to take part.

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\. Patient undergoing the procedure is older than 18 years, has severe aortic valve stenosis (according to ESC guidelines) and is planned for cardiac catheterization as part of the pre-operative (SAVR) or pre-percutaneous (TAVI) work up. 2\. The patient has an intermediate (50-90%) coronary lesion that requires further evaluation. 3\. The patient undergoing the procedure is male, or if female, has no childbearing potential or is not pregnant. Exclusion Criteria: 1. The procedure is an emergency and/or the patient is unstable. 2. Pregnancy or lactation 3. Haemodynamically unstable patients 4. Killip class III-IV heart failure 5. Previous coronary artery by-pass in the artery being assessed 6. Contra-indications for adenosine administration: severe asthma or pre-existing type 2 AV-block 7. No significant coronary artery disease (\<50% stenosis on angiography). 8. Critical coronary artery disease deemed by the Heart Team to require immediate revascularization 9. Patients will be excluded from the SPECT study (secondary objective) if they have a left main coronary stenosis \>50%, triple vessel disease, previous myocardial infarction in the same coronary artery \& tandem lesions (separated by \>10mm) requiring independent evaluation in the same coronary artery since these factors interfere with the SPECT analysis.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis coronary artery disorder

As listed by the trial registrant

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

Aortic stenosis Coronary artery disease

Contacts and locations

Locations

  • AZ Delta

    Roeselare, Belgium

  • UZ Leuven

    Leuven, Vlaams-brabant, 3000, Belgium

  • University hospital Antwerp

    Antwerp, Belgium

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