SOURCE ANZ - An observational study using registry data to assess safety and efficacy outcomes data in patients with diagnosed Aortic Valve Stenosis who may be eligible for replacing the aortic heart valve without the need for open heart surgery
Not Applicable
Active, not recruiting
- Conditions
- Severe Aortic StenosisCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12611001026910
- Lead Sponsor
- Edwards Lifesciences Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 133
Inclusion Criteria
Key inclusion critieria –
1. Aortic valve area <0.8 cm2
2. Patients with symptomatic, severe calcific degenerative aortic stenosis requiring AVR, and considered to have high risk of operative mortality or is ‘non-operable’.
Exclusion Criteria
Key Exclusion criteria –
1. Patients with non-valvular, non-calcific acquired or congenital aortic stenosis, with unicuspid or bicuspid aortic valve
2. Patients unsuitable for AVR via transfemoral or transapical approach
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method