KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance
ConditionAortic Valve Disease
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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 population
The target population includes adult candidates who require replacement of their native or prosthetic aortic valve, and the associated repair or replacement of a damaged or diseased ascending aorta.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Edwards KONECT RESILIA AVC
DeviceSurgical replacement of the aortic valve and ascending aorta with the Edwards KONECT RESILIA AVC
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Edwards KONECT RESILIA AVC1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participant's freedom from death and/or device related reintervention
Participants' freedom from valve-related death or valve- and/or graft-related reintervention. Time to events were estimated by Kaplan-Meier method.
Time frame
≤ 30 daysSecondary outcomes
1
Participant's linearized rate of thromboembolism
A linearized rate percentage is calculated by the following equation: \[(Total number of late adverse events in each category/total number of late patient years) x 100\]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
Time frame
Events occurring ≥ 31 days and up through 5 years post-implant2
Participant's linearized rate of valve thrombosis
A linearized rate percentage is calculated by the following equation: \[(Total number of late adverse events in each category/total number of late patient years) x 100\]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
Time frame
Events occurring ≥ 31 days and up through 5 years post-implant3
Participant's linearized rate of major paravalvular leak
A linearized rate percentage is calculated by the following equation: \[(Total number of late adverse events in each category/total number of late patient years) x 100\]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
Time frame
Events occurring ≥ 31 days and up through 5 years post-implant4
Participant's linearized rate of endocarditis
A linearized rate percentage is calculated by the following equation: \[(Total number of late adverse events in each category/total number of late patient years) x 100\]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
Time frame
Events occurring ≥ 31 days and up through 5 years post-implantSponsors and contacts
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Source ClinicalTrials.gov