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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
199
Operable subjects
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Macquarie Unversity Hospital
Macquarie Park, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
VARC-2 Composite Safety Endpoint
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.
Time frame: 30 days
All Cause Mortality
Time frame: 30 days
All Cause Mortality
Time frame: 12 months
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Royal North Shore Hospital
St Leonards, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
St Vincent's Hospital - MELBOURNE
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
...and 1 more locations