New heart device under study for aortic valve and aorta repair

NCT ID NCT07619872

Recruiting now Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study will follow up to 250 adults who receive the KONECT RESILIA device, which replaces both the aortic valve and the ascending aorta in one surgery. The goal is to see how safe and effective the device is in real-world use. Participants must have a diseased aortic valve and damaged aorta, and will be monitored for complications like death or need for another procedure.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: KONECT RESILIA aortic valved conduit (a device that replaces the aortic valve and part of the aorta)
What this could lead to: If successful, this could confirm that the KONECT RESILIA device is a safe and effective option for people needing combined aortic valve and aorta replacement.
What could go wrong: This is an observational study, not a randomized trial, so results may be less definitive. Risks include typical surgical complications like infection, bleeding, or device-related issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Aortic Valve Disease aortic valve disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AORTIC VALVE DISEASE

Contacts and locations

Locations

TUM Klinikum Deutsches Herzzentrum
RECRUITING

München, Bavaria, 80636, Germany

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