Blood test could predict clot risk after heart valve surgery

NCT ID NCT04234841

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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 Results may not be published yet.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)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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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.

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First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This study investigates whether a blood test measuring clotting and clot-busting markers can predict complications in patients undergoing aortic valve replacement. Researchers will follow 750 adults with aortic stenosis who receive either surgical or catheter-based valve replacement. The goal is to identify those at higher risk for blood clots, strokes, or other serious events, and to determine when that risk is greatest.

What this could mean

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

Active substance
blood test
What this could lead to
If successful, this blood test could help doctors identify patients at high risk of blood clots after aortic valve replacement, potentially preventing strokes and heart attacks.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. The biomarkers may not reliably predict complications in all patients.

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 750 people

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

Started

Feb 2020

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All patients undergoing surgical bioprosthetic aortic valve replacement and transcatheter aortic valve implantation

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. Male and female patients aged 18 years or over. 2. Patients diagnosed with aortic valve disease, undergoing surgical or transcatheter AVR and free of exclusion criteria below. 3. The patient is willing and able to understand the Patient Information Sheet and provide informed consent. 4. The patient agrees to comply with the study protocol, including phlebotomy and imaging as required at pre-specified time points. Exclusion Criteria: 1. Inability to provide valid informed consent. 2. Male and female patients aged \< 18 years of age. 3. The patient has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses. 4. The patient has a history of substance abuse or demonstrates signs or clinical features of active substance abuse or active psychiatric disease that may result in non-compliance with visits or inability to obtain venous access. 5. Alcohol consumption above recommended safe levels (i.e. more than 14 units per week owing to the potential effects of high alcohol levels on platelet reactivity). 6. Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study such as sepsis. 7. Any major bleeding diathesis or blood dyscrasia (platelets \< 70 x 109/l, Hb \< 8 g/dl, INR \> 1.4, APTT \> x 2 UNL, leucocyte count \< 3.5 x 109/l, neutrophil count \< 1 x 109/l). 8. Currently enrolled in an investigational device or drug trial. 9. Active or disseminated malignancy at the time of recruitment. Additionally, for those patients taking part in the additional 4D CT angiography substudy: 10. Any contraindications to CT angiography: renal failure (Cr\>250 μmol/L or eGFR\<30 mL/min) due to the additional risk of contrast medium nephrotoxicity; or allergy to iodine. 11. Women of childbearing age who have not had a hysterectomy and/or who may be breastfeeding.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • East and North Hertfordshire NHS Trust

    RECRUITING

    Stevenage, Hertforshire, SG1 4AB, United Kingdom

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