Valvular & structural heart diseaseCohort study
Early U.S. Real-World Experience With a Novel Intra-Annular Self-Expanding Valve for Transcatheter Aortic Valve Replacement
- Registry study
- prospectively collected, retrospectively analyzed
- STS/ACC TVT Registry
Authors' conclusion
Early U.S. experience with the Navitor valve demonstrates favorable early clinical and hemodynamic outcomes, with improved PPI rate associated with procedural experience.
Study context
- Population
- Patients with native AS at high or extreme risk treated with TAVR, US, January 2023–December 2024
- Participants
- 2,958 patients
- Outcome
- All-cause mortality or stroke
- Follow-up
- 30 days
Main finding
As reported in the abstract
30-day all-cause mortality or stroke
5.2%
30-day mortality
2.8%
30-day stroke
2.7%
Observational data: associations, not effects.
Further findings
Technical success
- Technical success rate
- 97.9%
In-hospital mortality
- In-hospital mortality rate
- 1.3%
Hemodynamics · 30 days
- Mean transvalvular gradient
- 7.3 ± 3.8 mm Hg
- Aortic valve area
- 1.98 ± 0.64 cm²
New permanent pacemaker implantation (PPI) by site experience (>20 cases vs fewer)
- Navitor Classic: reduced PPI rate with site experience beyond 20 cases
- 19.4% vs 13.5%; P = 0.0039
- Vision: reduced PPI rate with site experience beyond 20 cases
- 19.1% vs 10.6%; P = 0.047
KCCQ Overall Summary score · 30 days
- Improvement from baseline
- 23.8 points
- Baseline
- 52.1 ± 24.8
- 30 days
- 75.9 ± 22.6
- P
- P < 0.0001
Safety
Major vascular complications
- Major vascular complications
- 1.8%
New PPI
- New permanent pacemaker implantation
- 17.8%
Moderate or greater PVL · 30 days
- Moderate or greater PVL
- 1.8%
Original publication
Early U.S. Real-World Experience With a Novel Intra-Annular Self-Expanding Valve for Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. Published 9 January 2026. doi:10.1016/j.jcin.2025.10.053
Summarised from the published abstract; every number is checked against it