Avr Thrombosis OutcoMe Study
ConditionAortic Stenosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEast and North Hertfordshire NHS Trust
About this trial
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.
Eligibility criteria
Qualifiers
Male and female patients aged 18 years or over.
Patients diagnosed with aortic valve disease, undergoing surgical or transcatheter AVR and free of
Disqualifiers
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.
Inability to provide valid informed consent.
Male and female patients aged < 18 years of age.
Trial design
Treatments tested in this trial
- Blood test
Treatment groups
750 Participants
are divided into 2 treatment groupsSponsors and collaborators
East and North Hertfordshire NHS Trust
Lead sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov