NCT06518681

Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease

Prospective Clinical Trial Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (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 initial clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance.

Detailed description

The polymer aortic valve, PoliaValve, from HeartHIll Medical, is indicated as a replacement for patients with severe aortic valve disease, including severe aortic stenosis, severe aortic regurgitation, or both. These patients will be included in the study after systematic assessment that the subjects meet the criteria for inclusion in the study.

Conditions

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

Interventions

Type	Name	Description
DEVICE	PoliaValve (Aortic)	Aortic Valve Replacement

Timeline

• Start date: 2024-08-15
• Primary completion: 2024-12-30
• Completion: 2025-12-30
• First posted: 2024-07-24
• Last updated: 2024-12-16

Locations

1 site across 1 country: China