Aortic Stenosis
Conditions
Keywords
TAVI, SAVR
Brief summary
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.
Detailed description
Recent studies have highlighted the risk of peri-operative thrombosis in patients undergoing aortic valve replacement (AVR) and the subsequent risk of subclinical valve thrombosis in bioprosthetic AVR. The risk is significantly greater with transcatheter aortic valve implantation (TAVI) than surgical aortic valve replacement (SAVR), and can lead to stroke and other neurological events including death, and early valve failure secondary to restricted leaflet mobility. Whilst oral anticoagulation (OAC) can reduce thrombosis, OAC has been shown to significantly and unacceptably increase the risk of bleeding when applied to all-comers undergoing TAVI. It would therefore be desirable to identify which patients are at increased thrombosis risk so these can be targeted with antithrombotic medications, whilst avoiding unnecessary bleeding risk in low risk patients. In this study will aim to identify those patients at greatest risk of thrombosis using novel biomarkers (assessing thrombosis and thrombolysis), and note whether these tests are able to predict adverse events. The tests for thrombosis and thrombolysis will involve a blood draw, which will be taken at various time points in the study to signal the time point of greatest thrombogenicity, which may be dependent on anti-platelet and anticoagulant therapy that the patient is prescribed. Adverse events include MACCE (myocardial infarction, stroke, TIA (transient ischaemic attack) and death), systemic embolism, clinical and subclinical valve thrombosis, valve restriction and bleeding. 4D CT, echocardiography and clinical reviews will be performed at regular time points in the study to identify adverse events. The follow-up for each patent will be 5 years.
Interventions
DIAGNOSTIC_TESTBlood test
Blood test
Sponsors
East and North Hertfordshire NHS Trust
Royal Brompton & Harefield NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACCE | 5 years (total duration of study) | Myocardial infarction, Stroke, Transient Ischaemic Attack (TIA), death |
| Bleeding | 5 years (total duration of study) | BARC |
| Systemic embolism | 5 years (total duration of study) | — |
Secondary
| Measure | Time frame |
|---|---|
| Subclinical valve thrombosis | 5 years (total duration of study) |
| New/worsening AF | 5 years (total duration of study) |
Countries
United Kingdom
Contacts
CONTACTDiana A Gorog, MD,PhD,FRCP
CONTACTRahim Kanji, MBBS,MRCP
Outcome results
None listed