The SOLACE-AU Clinical Trial (SOLACE-AU)

March 25, 2019 updated by: Edwards Lifesciences

A Multicentre, Non-Randomised Controlled Study of the Safety, Performance, Quality of Life and Cost Effectiveness Outcomes of the Edwards SAPIEN XT™ Transcatheter Heart Valve in an Australian Population

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi-centre, prospective, consecutively enrolled, non-randomized clinical trial. The comparatator group will consist of subjects undergoing surgical aortic valve replacement in Cohort A of the PARTNER II Trial [NCT01314313].

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Macquarie Park, New South Wales, Australia, 2109
        • Macquarie Unversity Hospital
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • St. Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • The Prince Charles Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Melbourne, Victoria, Australia, 3065
        • St Vincent's Hospital - Melbourne
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital/Fiona Stanley Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 70 years
  • STS Score > 4
  • Heart team agrees on eligibility including assessment that TAVR or AVR is appropriate

Exclusion Criteria:

  • Age <70 years
  • Evidence of an acute myocardial infarction ≤ 30 days
  • Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
  • Stroke or transient ischemic attack (TIA) within 6 months of the procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
SAPIEN XT™ valve with the NovaFlex and NovaFlex+ delivery systems.
Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Operable subjects
Other Names:
  • Implantation of the Transcatheter Aortic Valve Prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VARC-2 Composite Safety Endpoint
Time Frame: 30 days

The primary endpoint is a VARC-2 Composite. It comprises of

  1. All cause mortality
  2. All stroke
  3. Life-threatening bleeding
  4. Acute kidney injury - Stage 3 (including renal replacement therapy)
  5. Coronary artery obstruction requiring intervention
  6. Major vascular complications
  7. Valve related dysfunction (requiring repeat procedure)

A composite endpoint is an endpoint that is a combination of multiple components.
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
All Cause Mortality
Time Frame: 12 months
12 months
All Cause Mortality
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Collaborators

Pacific Clinical Research Group

Investigators

  • Principal Investigator: Dr. Owen Christopher Raffel, The Prince Charles Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

August 8, 2018

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 30, 2012

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-14 (AP HM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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