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SOURCE XT REGISTRY

NCT01238497 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2954

Last updated 2020-08-28

No results posted yet for this study

Summary

This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing treatment with the commercially available Edwards SAPIEN XT™ Valve, and delivery devices.

Conditions

  • Severe Aortic Stenosis

Interventions

DEVICE

TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Patients eligible for either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29)

DEVICE

TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Patients eligible for transapical or transaortic access and any of the 3 valve sizes (23mm, 26mm or 29mm)

DEVICE

TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Patients eligible for transfemoral access and requiring a 29mm valve.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-08-31
Completion
2016-11-30
FDA Device
Yes

Countries

  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Poland
  • South Africa
  • Spain
  • Switzerland
  • United Kingdom

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 NCT01238497 on ClinicalTrials.gov