Valvular & structural heart diseaseCohort study
30-Day and 1-Year Outcomes of Navitor Transcatheter Aortic Valve in Low- or Intermediate-Risk Patients
- Prospective single-arm study
- multicentre
- performance goal
Clinical events adjudicated by an independent committee; imaging by a core laboratory
Authors' conclusion
The Navitor valve demonstrated favorable safety and performance outcomes at 12 months
Study context
- Population
- Severe aortic stenosis (AS) at low or intermediate surgical risk undergoing Navitor TAVR, 36 sites in Europe, Australia and Israel
- Participants
- 434 participants
- Exposure
- Low risk vs Intermediate risk
- Low riskn = 203
- Intermediate riskn = 231
- Outcome
- Effectiveness: moderate or greater paravalvular leak (PVL); safety: all-cause mortality or fatal stroke or stroke with disability (each vs a performance goal)
- Follow-up
- 30 days (PVL); 12 months (safety)
Main finding
As reported in the abstract
Moderate or greater paravalvular leak (PVL) at 30 days (performance goal (PG) 6.6%, P < 0.0001)
0%
All-cause mortality or fatal stroke or stroke with disability at 12 months, first 262 patients (PG 11.3%, P < 0.0001)
2.3%
Observational data: associations, not effects.
Further findings
Technical success
- Technical success
- 97.0%
- Procedural mortality
- 0
Hemodynamic performance · through 12 months
- Mean gradient
- 8.0 mm Hg
- Effective orifice area
- 1.8 cm²
Original publication
30-Day and 1-Year Outcomes of Navitor Transcatheter Aortic Valve in Low- or Intermediate-Risk Patients. JACC Cardiovasc Interv. Published 29 August 2025. doi:10.1016/j.jcin.2025.08.021
Summarised from the published abstract; every number is checked against it