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

NCT07619872

RecruitingN/A

Sponsor: Edwards Lifesciences

Conditions: Aortic Valve Disease

Interventions: Edwards KONECT RESILIA AVC

Countries: Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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%

Locations (1)

München, Bavaria, Germany