NCT04234841

Avr Thrombosis OutcoMe Study

Can Thrombosis and Fibrinolysis Markers in Patients Undergoing Aortic Valve Replacement Predict Outcome

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 750 (estimated)
• Sponsor: East and North Hertfordshire NHS Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, we 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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood test	Blood test

Timeline

• Start date: 2020-02-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2020-01-21
• Last updated: 2020-01-21

Locations

1 site across 1 country: United Kingdom