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NOT YET RECRUITING
NCT06737757
NA

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

Sponsor: Suzhou Hearthill Medical Technology Co.,LTD

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

198

Start Date

2024-12

Completion Date

2029-12

Last Updated

2024-12-30

Healthy Volunteers

No

Interventions

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