MedTrace Logo

China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population

NCT03466918 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-09-10

Study results available
· View outcomes & findings →

Summary

To evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

Conditions

  • Aortic Stenosis
  • Symptomatic Aortic Stenosis
  • Aortic Regurgitation

Interventions

DEVICE

SAPIEN 3 THV with the Commander delivery system

Edwards SAPIEN 3 Transcatheter Heart Valve is implanted using the Commander delivery system

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Prof Junbo GE · Zhongshan Hospital and Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-23
Primary Completion
2019-07-03
Completion
2024-06-19
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

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 NCT03466918 on ClinicalTrials.gov