Trials / Completed
CompletedNCT01675596
The SOLACE-AU Clinical Trial
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 199 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 70 Years
- Healthy volunteers
- Not accepted
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 \[NCT01314313\].
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TAVR Implantation of the Transcatheter Aortic Valve Prosthesis | Operable subjects |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2016-02-01
- Completion
- 2018-08-08
- First posted
- 2012-08-30
- Last updated
- 2019-04-16
- Results posted
- 2019-04-16
Locations
11 sites across 1 country: Australia
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01675596. Inclusion in this directory is not an endorsement.