Aortic Valve Disease
Conditions
Keywords
Bentall
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEdwards KONECT RESILIA AVC
Surgical replacement of the aortic valve and ascending aorta with the Edwards KONECT RESILIA AVC
Sponsors
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participant's freedom from death and/or device related reintervention | ≤ 30 days | Participants' freedom from valve-related death or valve- and/or graft-related reintervention. Time to events were estimated by Kaplan-Meier method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant's linearized rate of thromboembolism | Events occurring ≥ 31 days and up through 5 years post-implant | 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. |
| Participant's linearized rate of valve thrombosis | Events occurring ≥ 31 days and up through 5 years post-implant | 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. |
| Participant's linearized rate of major paravalvular leak | Events occurring ≥ 31 days and up through 5 years post-implant | 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. |
| Participant's linearized rate of endocarditis | Events occurring ≥ 31 days and up through 5 years post-implant | 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. |
| Participant's linearized rate of major hemorrhage | Events occurring ≥ 31 days and up through 5 years post-implant | 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. |
| Percentage of participant's with freedom from death and/or device related reintervention | 1-, 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, and 10- Years follow-up | Participants' freedom from valve-related death or valve- and/or graft-related reintervention. Time to events were estimated by Kaplan-Meier method. |
| Participant's functional improvement over time from baseline for New York Heart Association (NYHA) Class | Baseline, 1 month, 1-, 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, and 10- Years follow-up | The New York Heart Association functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or anginal syndrome may be present even at rest. |
| Participant's average mean gradient measurement over time | 1 month, 1-, 3-, and 5- Years follow-up | Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve. |
| Participant's average peak gradient measurement over time | 1 month, 1-, 3-, and 5- Years follow-up | Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve. |
| Participant's average Effective Orifice Area (EOA) measurement over time | 1 month, 1-, 3-, and 5- Years follow-up | Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve. |
| Participant's average Effective Orifice Area Index (EOAI) measurement over time | 1 month, 1-, 3-, and 5- Years follow-up | Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve. |
Countries
Germany
Contacts
CONTACTSabrina Hundt, PhD
PRINCIPAL_INVESTIGATORMarkus Krane, Prof. Dr. med.
TUM Universitätsklinikum Deutsches Herzzentrum
Outcome results
None listed