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REPRISE China - Clinical Evaluation in China

NCT03084510 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-11-15

No results posted yet for this study

Summary

To evaluate the safety and effectiveness of the Lotus Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic Chinese patients with calcific, severe native aortic stenosis who are considered at high risk for surgical valve replacement.

Conditions

  • Stenoses, Aortic Valve

Interventions

DEVICE

Lotus Edge™ Valve System

• The Lotus Edge™ Valve System consisting of two main components: * a bioprosthetic bovine pericardial aortic valve, and * a delivery system Device sizes include 23 mm, 25 mm and 27 mm diameter.

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Runlin GAO, Doctor · Cardiovascular Institute and Fu Wai Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-28
Primary Completion
2020-11-30
Completion
2020-11-30

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 NCT03084510 on ClinicalTrials.gov