Valvular & structural heart diseaseCohort study
Early Results of Multicenter Trial of a Novel Balloon-Expandable Valve With Anchor for Aortic Regurgitation
- Prospective single-arm multicentre trial
- ongoing
- objective performance criteria registration study
- 13 centres in mainland China
Authors' conclusion
The early results of the HAVE AR trial showed a low incidence of adverse safety events, especially low permanent pacemaker implantation rate, and good efficacy of the Hanchor Valve system for treating patients with severe PNAR at intermediate or high surgical risk.
Study context
- Population
- Patients with severe pure native aortic regurgitation (PNAR) at intermediate or high surgical risk
- Participants
- 128 patients
Main finding
As reported in the abstract
Procedural success
Procedural success, 123 of 128 patients
96.09%
Observational data: associations, not effects.
Further findings
Procedural characteristics
- Median oversizing ratio (Q1-Q3: 2.69%-6.83%)
- 5.10%
- Median implantation depth (Q1-Q3: 2-6 mm)
- 5 mm
Echocardiographic outcomes · 30 days
- Intravalvular aortic regurgitation or more than mild paravalvular regurgitation
- 0
- Median effective orifice area (Q1-Q3: 2.20-2.98 cm²)
- 2.50 cm²
Functional status and LV remodelling · 30 days
- Improvement in NYHA functional class
- P < 0.001
- Improvement in EQ-5D score
- P < 0.001
- Reduction in LV end-diastolic diameter
- P < 0.001
- Reduction in LV end-systolic diameter
- P < 0.001
- Increase in LVEF
- P = 0.007
Death · 30 days
- 3 of 128 patients
- 2.34%
Safety
Valve migration
- Valve migration (of 128)
- 3
- Second valve implantation (of 128)
- 2
- Conversion to surgery (of 128)
- 1
New permanent pacemaker implantation · 30 days
- 15 of 125 patients
- 12.00%
Major bleeding · 30 days
- 1 of 128 patients
- 0.78%
Original publication
Early Results of Multicenter Trial of a Novel Balloon-Expandable Valve With Anchor for Aortic Regurgitation. JACC Cardiovasc Interv. Published 24 March 2025. doi:10.1016/j.jcin.2024.12.006
Summarised from the published abstract; every number is checked against it