NCT07619872 KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance
| NCT ID | NCT07619872 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Edwards Lifesciences |
| Condition | Aortic Valve Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-06-25 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2026-06-25 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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%
Contact & Investigator
Markus Krane, Prof. Dr. med.
PRINCIPAL INVESTIGATOR
TUM Universitätsklinikum Deutsches Herzzentrum
Frequently Asked Questions
Who can join the NCT07619872 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07619872 currently recruiting?
Yes, NCT07619872 is actively recruiting participants. Contact the research team at Sabrina_Hundt@edwards.com for enrollment information.
Where is the NCT07619872 trial being conducted?
This trial is being conducted at München, Germany, Bonn, Germany, Berlin, Germany.
Who is sponsoring the NCT07619872 clinical trial?
NCT07619872 is sponsored by Edwards Lifesciences. The principal investigator is Markus Krane, Prof. Dr. med. at TUM Universitätsklinikum Deutsches Herzzentrum. The trial plans to enroll 250 participants.