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Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System

NCT05202977 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-01-24

No results posted yet for this study

Summary

This study was designed to preliminary verify the safety and of efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System With accessories in patients with symptomatic, calcified and severe aortic stenosis using objective performance criteria

Conditions

  • Transcatheter Aortic Valve Replacement

Interventions

DEVICE

SinocrownTM Transcatheter Aortic Valve Replacement System

Subjects receiving SinocrownTM Transcatheter Aortic Valve Replacement System of Lepu Medical

Sponsors & Collaborators

  • Lepu Medical Technology (Beijing) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yongjian Wu · Heifei High-tech Cardiovascular hospital

  • Weiyi Fang · Heifei High-tech Cardiovascular hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2021-08-07
Completion
2026-08-31

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 NCT05202977 on ClinicalTrials.gov