Avr Thrombosis Outcome in Aortic Valve Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study tracks patients with aortic valve disease undergoing either surgical or transcatheter valve replacement. Blood tests measuring thrombosis and thrombolysis are taken at multiple time points to see if they predict adverse events like heart attack, stroke, systemic embolism, or death, as well as subclinical valve thrombosis. The goal is to identify when thrombosis risk is highest and whether biomarker results can guide personalized antithrombotic treatment to balance bleeding risk. The analysis will relate biomarker signals to perioperative thrombotic events and valve-related complications. Imaging and phlebotomy are performed per protocol to support these endpoints.

Why it matters

Who can join: the full rules

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.

Where it's running

• East and North Hertfordshire NHS Trust
  Stevenage, Hertforshire, United Kingdom Recruiting

Study contacts

• Study coordinator: Diana A Gorog, MD,PhD,FRCP
• Email: d.gorog@imperial.ac.uk
• Phone: 01707247512

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.