Valvular & structural heart diseaseRandomised controlled trial
1-Year Outcomes of Novel Balloon-Expandable vs Contemporary Transcatheter Heart Valves in Severe Aortic Stenosis
- Randomised controlled trial
- open-label
- noninferiority
- multicentre (31 hospitals)
Authors' conclusion
In the treatment of symptomatic severe native aortic stenosis, the clinical and hemodynamic outcomes of the Myval THV series were comparable to those of contemporary THVs for the 1-year composite of all-cause mortality, all strokes, or procedure- or valve-related hospitalizations.
Study context
- Population
- Symptomatic severe native AS, 31 hospitals in Europe, New Zealand and Brazil
- Participants
- 768 participants
- Comparison
- Myval balloon-expandable transcatheter heart valve (THV) vs contemporary THVs
- Primary endpoint
- Freedom from composite endpoint (Kaplan-Meier)
- Follow-up
- 365 days
Primary result
As reported in the abstract
Difference
−0.1%
1-sided 95% CI 3.9%
P < 0.0001 for non-inferiority
By group
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
1-Year Outcomes of Novel Balloon-Expandable vs Contemporary Transcatheter Heart Valves in Severe Aortic Stenosis. J Am Coll Cardiol. Published 16 November 2025. doi:10.1016/j.jacc.2025.10.076
Summarised from the published abstract; every number is checked against it