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New heart device under study for aortic valve and aorta repair

NCT ID NCT07619872

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2039

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The target population includes adult candidates who require replacement of their native or prosthetic aortic valve, and the associated repair or replacement of a damaged or diseased ascending aorta.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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%

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • TUM Klinikum Deutsches Herzzentrum

    RECRUITING

    München, Bavaria, 80636, Germany

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