Valvular & structural heart disease

Randomized comparison of transcatheter aortic valve implantation (TAVI) valves: The Compare-TAVI trial

Am Heart JPublished Randomised controlled trial

Study context

Population
Patients scheduled for TAVI, preferably all comersplanned 1062
Planned comparison
Sapien 3/Sapien 3 Ultra Transcatheter Heart Valve (THV) vs Myval/Myval Octacor THV
Primary endpoint
Composite safety and efficacy endpoint: death, stroke, moderate-severe aortic regurgitation, moderate-severe valve deterioration
Follow-up
1 year
Methodological detailsdesign and rationale, non-inferiority, 1:1 randomisation, consecutive cohorts, Enrollment finalized in cohort B, Follow-up until withdrawal of consent, death or 10 years; secondary endpoints at 30 days, 1, 3, 5 and 10 years
  • Design and rationale
  • Non-inferiority
  • 1:1 randomisation
  • Consecutive cohorts
  • Enrollment finalized in cohort B
  • Follow-up until withdrawal of consent, death or 10 years; secondary endpoints at 30 days, 1, 3, 5 and 10 years

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

Original publication

Randomized comparison of TAVI valves: The Compare-TAVI trial. Am Heart J. Published 9 May 2024. doi:10.1016/j.ahj.2024.05.003

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