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Recruiting
NCT07619872
KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance
Conditions: Aortic Valve Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 250
Sponsor: Edwards Lifesciences
Location: TUM Klinikum Deutsches Herzzentrum München Bavaria
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.
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 \[eGFR\] \
Source: ClinicalTrials.gov (NCT07619872). StuddyBuddy aggregates publicly available trial information.
