NCT06737757

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

Prospective, Multicenter, Randomized Controlled, Non-Inferiority Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Suzhou Hearthill Medical Technology Co.,LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Aortic Valve Stenosis
• Aortic Valve Disease
• Aortic Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	Artificial polymer heart valves	The experimental group will use polymer material surgical aortic valves(PoliaValve, Hearthill Medical) for aortic valve replacement
DEVICE	Bovine pericardial aortic valve	The control group will undergo aortic valve replacement using bovine pericardial aortic valve

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-08-01
• Completion: 2029-12-01
• First posted: 2024-12-17
• Last updated: 2024-12-30