Valvular & structural heart diseaseCohort study
Mid-Term Outcomes of a Novel Transcatheter Aortic Valve Replacement (TAVR) Device for Pure Aortic Regurgitation
- Prospective single-arm clinical trial
- multicentre
- 15 centres
- consecutive patients
Authors' conclusion
This study demonstrates that the Pioneer Valve provides a safe and effective alternative for high-risk or inoperable patients with severe pure AR, achieving favorable mid-term outcomes with stable hemodynamic performance.
Study context
- Population
- Patients with severe pure native aortic regurgitation (AR), high surgical risk or inoperable
- Participants
- 110 patients
Main finding
As reported in the abstract
Mid-term efficacy and safety (VARC-3), up to 1 year · up to 1 year
Technical success
109 of 110 (99.1%)
Valve migration
1 case
Mean aortic valve gradient at 30 days
7.88 ± 2.7 mm Hg
Mean effective orifice area at 30 days
2.2 ± 0.64 cm²
Observational data: associations, not effects.
Further findings
All-cause mortality · up to 1 year
- All-cause mortality
- 3 of 110 (2.7%; 95% CI: 0.9%-8.3%)
Safety
New permanent pacemaker implantation
- New permanent pacemaker implantation
- 23 of 105 cases (21.9%; 95% CI: 14.3%-29.8%)
Original publication
Mid-Term Outcomes of a Novel TAVR Device for Pure Aortic Regurgitation. JACC Cardiovasc Interv. Published 22 December 2025. doi:10.1016/j.jcin.2025.10.017
Summarised from the published abstract; every number is checked against it