Avr Thrombosis OutcoMe Study

ConditionAortic Stenosis

Trial statusRecruiting

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

This trial does not accept healthy volunteers

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 population

All patients undergoing surgical bioprosthetic aortic valve replacement and transcatheter aortic valve implantation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Blood test
Diagnostic test
Blood test

Treatment groups

750 Participants

are divided into 2 treatment groups

Group A: Surgical Aortic Valve Replacement (SAVR)1 intervention

Group B: Transcatheter Aortic Valve Implantation (TAVI)1 intervention

Trial outcomes