Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease

The purpose of this study is to conduct the clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance. This prospective, multicenter, randomized controlled, non inferiority clinical trial is expected to enroll 198 subjects and conduct a 1:1 random grouping. The experimental group will use polymer material surgical aortic valves（PoliaVavle, HeartHill Medical, Suzhou China) for aortic valve replacement, while the control group will use bovine pericardial biological valves for aortic valve replacement.

NCT Number	NCT06737757
Lead Sponsor	Suzhou Hearthill Medical Technology Co.,LTD
Conditions	Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Regurgitation
Enrollment	198 participants
Start Date	2024-12
Primary Completion	2026-08 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2024-12-30