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ACTIVE NOT RECRUITING
NCT02426307

Subclinical Aortic Valve Bioprosthesis Thrombosis Assessed With 4D CT

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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.

Official title: Subclinical Aortic Valve biOprosthesis thRombosis Assessed With 4D Computed tomographY Imaging

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

OBSERVATIONAL

Enrollment

274

Start Date

2015-04

Completion Date

2030-04

Last Updated

2022-12-12

Healthy Volunteers

No

Interventions

PROCEDURE

TAVR

TAVR: Transcatheter Aortic Valve Replacement

PROCEDURE

SAVR

SAVR: surgical Aortic Valve Replacement

Locations (1)

Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen

Copenhagen, Denmark