Valvular & structural heart disease

Prospective study on the impact of different antithrombotic therapies on subclinical leaflet thickening and its temporal dynamics in transcatheter aortic valves—The NOTION-4 trial

Am Heart JPublished Randomised controlled trial

Study context

Population
Transcatheter aortic valve replacement (TAVR) patients with no indication for oral anticoagulant (OAC) therapyplanned enrolment
Participants
324 patients
Planned comparison
Early 3-month direct oral anticoagulant (DOAC) then SAPT vs lifelong SAPT after TAVR
Primary endpoint
Number of patients with ≥1 bioprosthetic aortic valve leaflet with HALT on cardiac 4DCT
Follow-up
1 year
Methodological detailsdesign paper, superiority, Enrolment started 2021; last patient expected by end of 2024, HALT and clinical endpoints evaluated at 3 months, 1 year and 5 years
  • Design paper
  • Superiority
  • Enrolment started 2021; last patient expected by end of 2024
  • HALT and clinical endpoints evaluated at 3 months, 1 year and 5 years

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Prospective study on the impact of different antithrombotic therapies on subclinical leaflet thickening and its temporal dynamics in transcatheter aortic valves—The NOTION-4 trial. Am Heart J. Published 5 October 2024. doi:10.1016/j.ahj.2024.10.002

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