Avr Thrombosis OutcoMe Study

NCT04234841 | Not Yet Recruiting

• 1 other identifier: RD2019-11
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Keywords

TAVI; SAVR

Outcome Measures

Primary Outcomes (3)

• MACCE

  Myocardial infarction, Stroke, Transient Ischaemic Attack (TIA), death

  5 years (total duration of study)

• Bleeding

  BARC

  5 years (total duration of study)

• Systemic embolism

  5 years (total duration of study)

Secondary Outcomes (2)

• Subclinical valve thrombosis

  5 years (total duration of study)

• New/worsening AF

  5 years (total duration of study)

Study Arms (2)

Surgical Aortic Valve Replacement (SAVR)

This cohort includes patients who will be undergoing surgical aortic valve replacement

Diagnostic Test: Blood test

Transcatheter Aortic Valve Implantation (TAVI)

This cohort includes patients who will be undergoing Transcatheter Aortic Valve Implantation

Diagnostic Test: Blood test

Interventions

Blood test DIAGNOSTIC_TEST

Blood test

Surgical Aortic Valve Replacement (SAVR); Transcatheter Aortic Valve Implantation (TAVI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male and female patients aged 18 years or over.

You may not qualify if:

• 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.
• 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.
• 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 illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study such as sepsis.
• 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).
• Currently enrolled in an investigational device or drug trial.
• Active or disseminated malignancy at the time of recruitment.
• Additionally, for those patients taking part in the additional 4D CT angiography substudy:
• 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.
• Women of childbearing age who have not had a hysterectomy and/or who may be breastfeeding.

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator

Study Sites (1)

East and North Hertfordshire NHS Trust

Stevenage, Hertforshire, SG1 4AB, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples obtained through phlebotomy

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Diana A Gorog, MD,PhD,FRCP

CONTACT

01707247512; d.gorog@imperial.ac.uk

Rahim Kanji, MBBS,MRCP

CONTACT

01438284753; rahim.kanji04@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 21, 2020
• Study Start: February 1, 2020
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)