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

NCT03314857 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-09-05

Study results available
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Summary

To evaluate the safety and effectiveness of the SAPIEN XT (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 XT THV with the NovaFlex+ delivery system

Edwards SAPIEN XT™ Transcatheter Heart Valve along with NovaFlex+ delivery system

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Runlin Gao · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2018-07-06
Completion
2023-06-15
FDA Device
Yes

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 NCT03314857 on ClinicalTrials.gov