Clinical Trial

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

Enrolling by Invitation
View on ClinicalTrials.gov →
Record status
This record was last updated December 16, 2024 (before its estimated December 30, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-07-22.
Status change: Not Yet Recruiting → Enrolling by Invitation 2024-12-11
Trial Details
NCT Number NCT06518681
Lead Sponsor Suzhou Hearthill Medical Technology Co.,LTD
Conditions Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Regurgitation
Enrollment 10 participants
Start Date 2024-08-15
Primary Completion 2024-12-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2024-12-16