Subclinical Aortic Valve Bioprosthesis Thrombosis Assessed With 4D CT

Condition(s) studied

Investigational drug(s) / intervention(s)

TAVR: TAVR: Transcatheter Aortic Valve Replacement

SAVR: SAVR: surgical Aortic Valve Replacement

Study summary

TAVR is an increasingly used technique for the treatment of aortic valve stenosis. However, recent clinical experience has suggested that subclinical aortic valve bioprosthesis thrombosis may occur early after valve replacement. The frequency of this potentially ominous phenomenon on both transcatheter and surgical aortic valve bioprosthesis is unknown, as this condition is difficult to detect.

The recent development of cardiac 4D computed tomography imaging (4DCT) shows great promise for the evaluation of valve leaflet mobility and morphology.

The purpose of this study is in an observational design to assess the frequency of subclinical abnormal leaflet motion and morphology in patients treated with transcatheter or surgical aortic valve bioprosthesis. In addition, the 'natural evolution' of this phenomenon as well as its relation to medical treatment and MACCE will be assessed.

Eligibility

Primary outcome measure(s)

• Frequency of patients with abnormal aortic valve bioprosthesis leaflet mobility and morphology — At least 21 days post-procedure

Trial sites (1)

More Rigshospitalet, Denmark trials in Denmark

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