N/A
N=199
The SOLACE-AU Clinical Trial
Severe, Symptomatic Aortic Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01675596 ↗Enrolled (actual)
199
Serious AEs
36.7%
Results posted
Apr 2019
Primary outcome: Primary: VARC-2 Composite Safety Endpoint — 12.1 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TAVR Implantation of the Transcatheter Aortic Valve Prosthesis (Device)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VARC-2 Composite Safety Endpoint |
12.1 | — |
| SECONDARY All Cause Mortality |
8.5 | — |
| SECONDARY All Cause Mortality |
8.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01675596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.