Blood test could predict clot risk after heart valve surgery
NCT ID NCT04234841
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
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About 750 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2020
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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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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
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East and North Hertfordshire NHS Trust
RECRUITINGStevenage, Hertforshire, SG1 4AB, United Kingdom
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Other studies related to the condition(s) this trial covers.
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- Can a less invasive valve replacement tame a failing aortic valve?
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