Assessing standard oF care and clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, active, pOst-market surveillaNce study.
- Conditions
- Aortic Valve Replacement10046973
- Registration Number
- NL-OMON39322
- Lead Sponsor
- Edwards Lifesciences SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Subject is 18 years or older
2. Subject presents with aortic stenosis or stenosis-based insufficiency of an aortic valve requiring a planned replacement of the native aortic valve or previously implanted aortic prosthesis.
3. Subject has signed and dated the investigation informed consent forms prior to study-specific procedures are performed.
4. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.
Exclusion Criteria
1. History of active endocarditis within three months of scheduled surgery
2. Subject is diagnosed with pure aortic insufficiency
3. Aneurysm of the aortic root and/or ascending aorta
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method