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Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System

NCT04744857 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2021-02-21

No results posted yet for this study

Summary

The TaurusOne® transcatheter aortic valve system with retrievable delivery catheter system is evaluated the safety and effectiveness for the delivery of artificial aortic valve in a prospective, multicenter, single-arm clinical trial.

Conditions

  • Aortic Stenosis

Interventions

COMBINATION_PRODUCT

The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.

Using the grip-loading system, the artificial aortic valve was squeezed and loaded into the sheath of the transporter through the vascular approach.The artificial aortic valve is delivered and positioned at the correct anatomical position for release. For example, the artificial main valve is displayed after partial release If the aortic valve is not in the correct anatomical position, the artificial aortic valve can be recovered and placed into the sheath tube of the transporter for re-positioning and release.

Sponsors & Collaborators

  • General Hospital of Shenyang Military Region

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • The Second Affiliated Hospital of Harbin Medical University

    collaborator OTHER

  • Air Force Military Medical University, China

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Beijing Anzhen Hospital

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • Central South University

    collaborator OTHER

  • Fu Wai Hospital, Beijing, China

    collaborator OTHER

  • China National Center for Cardiovascular Diseases

    collaborator OTHER_GOV

  • Shanghai Lingsi Medical Technology Co., Ltd.

    collaborator OTHER

  • Peijia Medical Technology (Suzhou) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-13
Primary Completion
2020-10-16
Completion
2020-10-16

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 NCT04744857 on ClinicalTrials.gov