CRT 2026 | NAVITOR IDE: Hemodynamic Outcomes and 5-Year Durability of an Intra-Annular Self-Expanding Transcatheter Aortic Valve

As TAVI expands into younger populations and patients with lower surgical risk, prosthesis durability has become a key aspect of long-term management. The NAVITOR IDE study evaluated the long-term clinical and hemodynamic outcomes of the intra-annular self-expanding Navitor valve.

This was a prospective, multicenter study conducted at 26 centers across Europe, Australia, and the United States. A total of 260 patients with symptomatic severe aortic stenosis who were considered at high or extreme surgical risk were included.

The analysis presented corresponds to the CE-mark cohort (n=120), with clinical and echocardiographic follow-up up to 5 years.

The safety analysis showed favorable long-term outcomes. All-cause mortality was 37.1% at 5 years (consistent with the high surgical risk profile of the included population). The cumulative incidence of stroke was 12.2%.

Regarding the hemodynamic profile during follow-up, long-term stability was observed. At five years the following values were reported:

• Mean aortic gradient: 6.9 mmHg

• Effective orifice area (EOA): approximately 2.0 cm²

• Low incidence of major paravalvular leak during follow-up (likely related to the active sealing cuff system).

Device durability was favorable throughout follow-up. At five years, bioprosthetic valve deterioration (BVD) was observed in 5.9% of patients, structural valve deterioration (SVD) in 0%, and valve reintervention in 0%.

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The authors noted that the 35 mm valve size was introduced later and was not included in the presented analysis.

The results of the NAVITOR IDE study demonstrate sustained hemodynamic performance and favorable five-year durability of the intra-annular self-expanding Navitor valve in patients with severe aortic stenosis at high surgical risk.

Presented by Bassem Chehab in the Late Breaking Clinical Trials session, CRT 2026, Washington, USA.