Thirty-Day And One-Year Outcomes Of Navitor Transcatheter Aortic Valve In Low- or Intermediate-Risk Patients.

Background: The Navitor transcatheter aortic valve is a self-expanding, intra-annular valve indicated for patients with severe aortic stenosis (AS) at high or extreme surgical risk.

Objectives: To assess the safety and effectiveness of the Navitor valve in severe AS patients at low or intermediate surgical risk.

Methods: VANTAGE is a prospective, single-arm, multicenter study. The primary effectiveness endpoint was moderate or greater paravalvular leakage (PVL) at 30 days; the primary safety endpoint was all-cause mortality or fatal stroke/stroke with disability at 12 months. Both endpoints were assessed against a performance goal (PG) when the sample size requirements were met. Clinical events and imaging assessments were evaluated by an independent committee and a core laboratory, respectively.

Results: A total of 434 patients (203 low-risk, 231 intermediate-risk) underwent Navitor implantation between July 2021 and November 2024 across 36 sites in Europe, Australia, and Israel. The mean STS-PROM scores were 1.5% and 2.6% for the low- and intermediate-risk groups. Technical success was 97.0%, with no procedural mortality. At 30 days, no patients had moderate or greater PVL (0%), which was significantly below the PG of 6.6% (p<0.0001). In the first 262 patients with 12-month follow-up completed, the rate for all-cause mortality or fatal stroke/stroke with disability was 2.3%, also significantly below the PG of 11.3% (p<0.0001). Sustained hemodynamic performance (mean gradient 8.0 mmHg, effective orifice area 1.8 cm²) was seen through 12 months.

Conclusion: Navitor demonstrated favorable safety and performance outcomes at 12 months, supporting its expansion to low- and intermediate-risk populations.