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Clinical Trial Summary

A randomized clinical trial investigating the incidence and temporal dynamics of subclinical leaflet thickening by cardiac CT in transcatheter bioprosthetic aortic valves in patients randomised to different anti-thrombotic strategies. Additionally, this study aims to examine a possible association between HALT and thromboembolic events.


Clinical Trial Description

The NOTION-4 trial is an investigator-initiated, randomized, open label, comparative trial conducted at Rigshospitalet in Copenhagen and Skejby Sygehus in Aarhus. All adult patients that have undergone successful TAVI without contraindications for cardiac CT will be invited to participate in this study. Patients with SR and without known other indication for chronic OAC therapy will be randomized 1:1 either to lifelong ASA or to 3 months of DOAC followed by lifelong ASA. Patients with known AF will be randomized 1:1 to lifelong DOAC versus LAAC within 3 months followed by lifelong ASA. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06449469
Study type Interventional
Source Rigshospitalet, Denmark
Contact Jani Thuraiaiyah, MD
Phone 35456342
Email jani.thuraiaiyah@regionh.dk
Status Recruiting
Phase N/A
Start date May 1, 2021
Completion date January 1, 2029

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