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

NCT06737757 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2024-12-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Suzhou Hearthill Medical Technology Co.,LTD

    lead INDUSTRY

Principal Investigators

  • Fanglin Lu, MD · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  • Xiangbin Pan, MD · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2026-08-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06737757 on ClinicalTrials.gov