About this trial
KONECTION is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in up to 250 participants who will receive the KONECT RESILIA aortic valved conduit, Model 11060A.
Eligibility criteria
Qualifiers
18 years or older at the time of informed consent
Have a diseased native or prosthetic aortic valve and a damaged or diseased ascending aorta that requires aortic valved conduit replacement surgery with the KONECT RESILIA AVC
Provide written informed consent
Willing to follow protocol requirements
Disqualifiers
Active endocarditis or endocarditis within 3 months prior to the study index procedure
Emergency procedure
Stage 4 renal disease (estimated glomerular filtration rate [eGFR] <30 excluded) or requiring dialysis
Less than 2-year life expectancy due to non-cardiovascular life-threatening disease in the opinion of the study investigator
Trial design
Treatments tested in this trial
- Edwards KONECT RESILIA AVC