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The SOLACE-AU Clinical Trial (SOLACE-AU)

Primary Purpose

Severe, Symptomatic Aortic Stenosis

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe, Symptomatic Aortic Stenosis focused on measuring Aortic Stenosis, Transfemoral, Transcatheter Heart Valve

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Prince Alfred Hospital
  • Macquarie Unversity Hospital
  • Prince of Wales Hospital
  • Royal North Shore Hospital
  • The Prince Charles Hospital
  • Royal Adelaide Hospital
  • Flinders Medical Centre
  • The Alfred Hospital
  • St Vincent's Hospital - MELBOURNE
  • Royal Melbourne Hospital
  • Royal Perth Hospital/Fiona Stanley Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test

Arm Description

SAPIEN XT™ valve with the NovaFlex and NovaFlex+ delivery systems.

Outcomes

Primary Outcome Measures

VARC-2 Composite Safety Endpoint
The primary endpoint is a VARC-2 Composite. It comprises of All cause mortality All stroke Life-threatening bleeding Acute kidney injury - Stage 3 (including renal replacement therapy) Coronary artery obstruction requiring intervention Major vascular complications Valve related dysfunction (requiring repeat procedure) A composite endpoint is an endpoint that is a combination of multiple components.

Secondary Outcome Measures

All Cause Mortality
All Cause Mortality

Full Information

First Posted
August 28, 2012
Last Updated
March 25, 2019
Sponsor
Edwards Lifesciences
Collaborators
Pacific Clinical Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT01675596
Brief Title
The SOLACE-AU Clinical Trial
Acronym
SOLACE-AU
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
August 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
Collaborators
Pacific Clinical Research Group

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe, Symptomatic Aortic Stenosis
Keywords
Aortic Stenosis, Transfemoral, Transcatheter Heart Valve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
SAPIEN XT™ valve with the NovaFlex and NovaFlex+ delivery systems.
Intervention Type
Device
Intervention Name(s)
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Other Intervention Name(s)
Implantation of the Transcatheter Aortic Valve Prosthesis
Intervention Description
Operable subjects
Primary Outcome Measure Information:
Title
VARC-2 Composite Safety Endpoint
Description
The primary endpoint is a VARC-2 Composite. It comprises of All cause mortality All stroke Life-threatening bleeding Acute kidney injury - Stage 3 (including renal replacement therapy) Coronary artery obstruction requiring intervention Major vascular complications Valve related dysfunction (requiring repeat procedure) A composite endpoint is an endpoint that is a combination of multiple components.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
All Cause Mortality
Time Frame
30 days
Title
All Cause Mortality
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Owen Christopher Raffel
Organizational Affiliation
The Prince Charles Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Macquarie Unversity Hospital
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
St Vincent's Hospital - MELBOURNE
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Perth Hospital/Fiona Stanley Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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The SOLACE-AU Clinical Trial

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