KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance
Recruiting
Observational Study
Aortic Valve Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 250 (estimated)
- Sponsor
- Edwards Lifesciences · Industry
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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.
Trial Locations
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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 …
Contacts