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Study on Aortic Stenosis: Evaluating Fludeoxyglucose (18F) for Patients with Conduction Disorders After Aortic Valve Procedures

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a condition called aortic stenosis, which is a narrowing of the heart's aortic valve. The study will use a special imaging technique called positron emission tomography (PET) to observe how inflammation in the heart's conduction pathways might affect heart function after a procedure known as percutaneous aortic valve replacement. The imaging will involve a substance called Fludeoxyglucose (18F), which is injected into the body to help highlight areas of inflammation during the PET scan.

The purpose of the study is to explore the relationship between inflammation and the development of conduction disorders, which are problems with the heart's electrical system that can occur after the valve replacement procedure. Participants will undergo PET scans to assess inflammation levels and will be monitored for any conduction disorders during their hospital stay and for up to six months afterward. This includes checking for issues like complete or partial heart block, which can affect how the heart beats.

Throughout the study, participants may also be evaluated for the need for a pacemaker, a device that helps control abnormal heart rhythms. The study aims to provide insights into how inflammation might influence the heart's electrical pathways and potentially lead to better management of patients undergoing valve replacement procedures. The findings could help improve understanding and treatment of conduction disorders in patients with aortic stenosis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after providing informed consent. Eligibility includes being over 18 years old, having aortic stenosis, and meeting specific health criteria.

  2. Step 2

    Initial hospitalization

    During the initial hospital stay, the focus is on monitoring for any conduction disorders. This involves electrocardiograms (ECGs) after the percutaneous valve procedure.

  3. Step 3

    Medication administration

    The medication used is fludeoxyglucose (18F), administered as a solution for injection. It is given through an intravenous injection to help assess inflammation in the heart's conduction pathways.

  4. Step 4

    Post-procedure monitoring

    After the valve procedure, monitoring continues for any conduction disorders. This includes checking for complete or high-grade atrioventricular block (AVB), left or right bundle branch block (LBB/RBB), and first-degree AVB.

  5. Step 5

    Pacemaker evaluation

    If necessary, a pacemaker may be implanted after the procedure. Dependence on the pacemaker is assessed at 1 month and 6 months post-implantation.

  6. Step 6

    Follow-up period

    The follow-up period extends up to 6 months after discharge from the initial hospitalization. During this time, any occurrence of conduction disorders is monitored.

Who can join the trial?

8 criteria

  • Patients must be over 18 years of age.
  • Patients must have **tight aortic stenosis**, which means the heart's aortic valve is narrowed. This is defined by:
    • Aortic valve area is less than or equal to 1 square centimeter, or less than or equal to 0.6 square centimeters per square meter of body surface area.
    • Maximum speed of blood flow through the valve is 4 meters per second or more.
    • Average pressure difference across the valve is 40 millimeters of mercury or more.
    • Patients must have symptoms such as **dyspnea** (difficulty breathing) that is stage 2 or higher according to the New York Heart Association (NYHA) classification. Alternatively, they may have a problematic stress test showing symptoms during exercise, a drop in blood pressure, or heart rhythm issues during exercise. If they are asymptomatic, they must have a **Left Ventricular Ejection Fraction (LVEF)** of less than 50%, which means the heart is not pumping as well as it should.
    • Patients must have blood vessel anatomy that allows for a **percutaneous femoral valve implantation**, which is a procedure to replace the aortic valve through the blood vessels in the leg.
    • Patients must be affiliated with or benefit from a health insurance scheme.
    • Patients must provide free, informed, and written consent to participate in the study.

Who cannot join the trial?

4 criteria

  • Patients with a condition called aortic stenosis cannot participate. This is a problem where the valve in the heart that controls blood flow from the heart to the rest of the body becomes narrow.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for participants in certain age groups.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, are not included in this study.
  • Both men and women can participate, but if a patient does not meet other specific criteria, they may be excluded.
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Investigated drugs

18F-FDG PET-CT is a type of imaging test used in this study to observe inflammation in the heart's conduction pathways. It helps doctors see how much inflammation is present, which might be linked to heart rhythm problems after a valve procedure.

What is already known about the treatment

18F-FDG – This medication is administered through an intravenous injection and is used in positron emission tomography (PET) scans. It is currently utilized in medical research and practice to assess metabolic activity and inflammation in tissues. The main therapeutic indication for 18F-FDG in this context is to evaluate inflammation in the heart's conduction pathways, particularly after procedures like percutaneous aortic valve replacement. At the molecular level, 18F-FDG acts by mimicking glucose, allowing it to highlight areas of increased metabolic activity, which are often indicative of inflammation or disease. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Aortic stenosis – Aortic stenosis is a condition where the aortic valve in the heart becomes narrowed, restricting blood flow from the heart to the rest of the body. This narrowing can lead to increased pressure within the heart, causing the heart muscle to thicken and potentially weaken over time. As the condition progresses, individuals may experience symptoms such as chest pain, shortness of breath, and fatigue, especially during physical activity. In severe cases, the reduced blood flow can lead to dizziness or fainting. The progression of aortic stenosis can vary, with some individuals remaining stable for years, while others may experience a rapid worsening of symptoms. Regular monitoring and medical evaluation are essential to assess the severity and impact of the condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514587-44-00Protocol code29BRC21.0255Estimated enrolment100 patientsSponsorCentre Hospitalier Regional Et Universitaire De Brest

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