Avr Thrombosis OutcoMe Study
Key facts
- Where
- Stevenage, United KingdomSee the site
Where in United Kingdom
- East and North Hertfordshire NHS TrustStevenage, United KingdomContact: Diana A Gorog, MD,PhD,FRCPTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- East and North Hertfordshire NHS Trust
- Trial code
- NCT04234841
- Record updated
- 15 July 2026
- Original description
This study aims to utilise novel biomarkers assessing thrombosis and thrombolysis (through a blood test), to identify patients undergoing either surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) who are at risk of thrombosis, and relate this to clinical thrombotic and thromboembolic adverse events and subclinical valve thrombosis, and identify the timeframe of greatest risk for valve thrombosis.Read full original descriptionShow less
Can Thrombosis and Fibrinolysis Markers in Patients Undergoing Aortic Valve Replacement Predict Outcome
This study aims to utilise novel biomarkers assessing thrombosis and thrombolysis (through a blood test), to identify patients undergoing either surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) who are at risk of thrombosis, and relate this to clinical thrombotic and thromboembolic adverse events and subclinical valve thrombosis, and identify the timeframe of greatest risk for valve thrombosis.
Inclusion: Male and female patients aged 18 years or over; Patients diagnosed with aortic valve disease, undergoing surgical or transcatheter AVR and free of exclusion criteria below; The patient is willing and able to understand the Patient Information Sheet and provide informed consent; The patient agrees to comply with the study protocol, including phlebotomy and imaging as required at pre-specified time points.
Exclusion: Currently enrolled in an investigational device or drug trial; 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; 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; Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study such as sepsis; Active or disseminated malignancy at the time of recruitment; Additionally, for those patients taking part in the additional 4D CT angiography substudy:; 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); 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); 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; Male and female patients aged < 18 years of age; Women of childbearing age who have not had a hysterectomy and/or who may be breastfeeding; Inability to provide valid informed consent.