Severe, Symptomatic Aortic Stenosis Clinical Trial
— SOLACE-AUOfficial title:
A Multicentre, Non-Randomised Controlled Study of the Safety, Performance, Quality of Life and Cost Effectiveness Outcomes of the Edwards SAPIEN XTâ„¢ Transcatheter Heart Valve in an Australian Population
NCT number | NCT01675596 |
Other study ID # | 2011-14 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2012 |
Est. completion date | August 8, 2018 |
Verified date | March 2019 |
Source | Edwards Lifesciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 199 |
Est. completion date | August 8, 2018 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Flinders Medical Centre | Bedford Park | South Australia |
Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
Australia | The Prince Charles Hospital | Chermside | Queensland |
Australia | Macquarie Unversity Hospital | Macquarie Park | New South Wales |
Australia | St Vincent's Hospital - MELBOURNE | Melbourne | Victoria |
Australia | The Alfred Hospital | Melbourne | Victoria |
Australia | Royal Melbourne Hospital | Parkville | Victoria |
Australia | Royal Perth Hospital/Fiona Stanley Hospital | Perth | Western Australia |
Australia | Prince of Wales Hospital | Randwick | New South Wales |
Australia | Royal North Shore Hospital | St. Leonards | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Edwards Lifesciences | Pacific Clinical Research Group |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
30 days | |
Secondary | All Cause Mortality | 30 days | ||
Secondary | All Cause Mortality | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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