KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance

KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance

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.

Subjects in the KONECTION study will be enrolled at up to 20 sites in Europe and Canada. The population will be participants requiring replacement of their diseased native or prosthetic aortic valve, and the associated repair or replacement of a damaged or diseased ascending aorta.

Inclusion Criteria:

1. 18 years or older at the time of informed consent
2. 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
3. Provide written informed consent
4. Willing to follow protocol requirements

Exclusion Criteria:

1. Active endocarditis or endocarditis within 3 months prior to the study index procedure
2. Emergency procedure
3. Stage 4 renal disease (estimated glomerular filtration rate [eGFR] <30 excluded) or requiring dialysis
4. Less than 2-year life expectancy due to non-cardiovascular life-threatening disease in the opinion of the study investigator
5. High predicted risk of mortality prior to the procedure: Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) ≥8%