Surgical Replacement and Transcatheter Aortic Valve Implantation Trial 10 Year Follow-up
Recruiting
- Conditions
- severe aortic valve stenosis10046973
- Registration Number
- NL-OMON45149
- Lead Sponsor
- Medtronic B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
All subjects currently enrolled in the randomized cohort of the SURTAVI trial
are eligible to consent to 10 year follow-up.
Exclusion Criteria
None
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of the 10 Year follow-up study is prospectively evaluate<br /><br>all-cause mortality or disabling stroke annually up to 10 years between TAVI<br /><br>(Transcatheter Aortic Valve Implantation) and SAVR (Surgical Aortic Valve<br /><br>Replacement).</p><br>
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular pathways are affected by transcatheter aortic valve implantation (TAVI) in severe aortic stenosis patients over 10 years?
How does 10-year survival with TAVI compare to surgical aortic valve replacement (SAVR) in high-risk aortic stenosis patients?
Which biomarkers correlate with improved 10-year outcomes following TAVI in NL-OMON45149 Medtronic-sponsored trial?
What long-term adverse events are reported in Medtronic CoreValve/Sapien systems during SURTAVI 10-year follow-up?
How does Medtronic's TAVI technology compare to Edwards Lifesciences Sapien 3 in 10-year durability and re-intervention rates?