Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
NCT Number: NCT06518681
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aortic Valve Disease|Aortic Valve Stenosis|Aortic Valve Regurgitation
Interventions: DEVICE: PoliaValve (Aortic)
Sponsor: Suzhou Hearthill Medical Technology Co.,LTD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-12-30
Locations: Shanghai General Hospital, Shanghai, Shanghai, China

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.

Primary Outcome Measures: Compliance rate of prosthetic valve function, The compliance rate of prosthetic valve function evaluation at 1 month after surgery. The standard of prosthetic valve function is as follows: prosthetic valve pressure difference \<20mmHg or peak flow rate \< 3m/s, no moderate or above intravalvular regurgitation or paravalvular leakage), and no reintervention is required., 1 month following patient enrollment completion|Surgery success rate, Event-free survival of the prosthetic valve at 12 months postoperatively. Prosthetic valve degeneration includes stenosis and/or regurgitation due to structural abnormalities of the valve itself (e.g., leaflet tears, detachment, calcification, fibrosis, deformation of the valve frame, and fracture of the material of the connecting parts between the valve components) (referred to as structural valve degeneration), as well as dysfunction due to infective endocarditis, perivalvular leakage, valve prosthesis-patient mismatch, valve displacement, and leaflet thrombosis (referred to as nonstructural valve degeneration). Prosthetic valve degeneration usually consists of three stages, with the first stage consisting of morphological evidence of valve degeneration and structural abnormalities, before significant hemodynamic changes are evident., 1 month following patient enrollment completion
Secondary Outcome Measures: EOA, Use echocardiography to evaluate the effective valve orifice area(EOA) to assess the hemodynamic Performance., baseline and 1 month following patient enrollment completion|Mean transvalvular pressure difference, Use echocardiography to measure the mean transvalvular pressure difference., baseline and 1 month following patient enrollment completion|Peak flow velocity, Use echocardiography to measure the peak flow velocity., baseline and 1 month following patient enrollment completion|Regurgitation, Evaluate the presence or absence of intravalvular or paravalvular regurgitation during the follow-up period by echocardiography., 1 month following patient enrollment completion|New York Heart Association Assessment (NYHA), Evaluate New York Heart Association Assessment (NYHA) to see Heart Function Improvement., baseline and 1 month following patient enrollment completion|BNP or NT-proBNP, Measure BNP or NT-proBNP to get the changes in postoperative cardiac function from baseline., baseline and 1 month following patient enrollment completion