N/A
N=516
EDWARDS INTUITY Valve System FOUNDATION Study
Aortic Valve Disease · Aortic Stenosis · Rapid Deployment Valves
Bottom Line
View on ClinicalTrials.gov: NCT02338154 ↗Enrolled (actual)
516
Serious AEs
47.5%
Results posted
Oct 2019
Primary outcome: Primary: Subject's Average Time Spent on Cardiopulmonary Cross Clamp — 59.7 minutes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject's Average Time Spent on Cardiopulmonary Cross Clamp |
59.7 | — |
Summary
The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.
The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.
Eligibility Criteria
Inclusion Criteria
- Subject is 18 years or older
- 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.
- Subject has signed and dated the investigation informed consent forms prior to study-specific procedures are performed.
- Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.
Exclusion Criteria
- History of active endocarditis within three months of scheduled surgery
- Subject is diagnosed with pure aortic insufficiency
- Aneurysm of the aortic root and/or ascending aorta
Data sourced from ClinicalTrials.gov (NCT02338154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.