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 cm) 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.