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PrizValve® Transcatheter Aortic Valve Replacement Study

NCT04836897 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-11-15

No results posted yet for this study

Summary

The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

PrizValve® valve and transapical delivery system

Transcatheter aortic valve replacement system

Sponsors & Collaborators

  • Shanghai NewMed Medical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chen mao, Chief · Study Principal Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-19
Primary Completion
2023-06-19
Completion
2028-06-30

Countries

  • China

Study Locations

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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 NCT04836897 on ClinicalTrials.gov