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The SOLACE-AU Clinical Trial

NCT01675596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2019-04-16

Study results available
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Summary

The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.

Conditions

  • Severe, Symptomatic Aortic Stenosis

Interventions

DEVICE

TAVR Implantation of the Transcatheter Aortic Valve Prosthesis

Operable subjects

Sponsors & Collaborators

  • Pacific Clinical Research Group

    collaborator OTHER

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Dr. Owen Christopher Raffel · The Prince Charles 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
2012-04-30
Primary Completion
2016-02-29
Completion
2018-08-08
FDA Device
Yes

Countries

  • Australia

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 NCT01675596 on ClinicalTrials.gov