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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEdwards Lifesciences

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

Treatment groups

250 Participants
are divided into 1 treatment group

Sponsors and collaborators