Heart valve repair device tracked for 10 years in new study

NCT ID NCT07413926

Disease control Sponsor: Artivion Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 110 patients who had mitral valve repair surgery using the Chord-X system to see how well the device holds up over 10 years. Researchers will check for return of moderate-to-severe mitral regurgitation and other safety issues. Participants agree to share their medical history and attend routine follow-up visits. The goal is to improve future care for people with leaky heart valves.

What this could mean

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

Active substance: Chord-X system implant (a device to repair the mitral valve)
What this could lead to: If successful, this study could confirm that the Chord-X device provides lasting repair for mitral regurgitation, reducing the need for repeat surgeries.
What could go wrong: This is an observational follow-up study, not a controlled trial, so it cannot prove the device works better than alternatives. Results depend on routine clinic visits and may not apply to all patients.

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 110 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2034

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

In this study, all patients who underwent a mitral valve procedure (defined as a mitral valve surgical intervention via either endoscopic, mini thoracotomy, or full sternotomy approach, including mitral annuloplasty with a ring, resection of mitral valve leaflets, and replacement of mitral chordae tendineae) using the Chord-X System, as clinically indicated, approximately 3 years prior to enrollment (beginning in January 2022), will be approached for participation in the study. Approximately 110 patients will be enrolled at five medical centers in the UK, EU and the United States. To ensure balanced representation across centers, each center will be expected to enroll a minimum of 15 patients and a maximum of 30 patients. 110 patients are planned for enrollment with the possibility to recruit up to 10 more patients for a total of 120 patients. Data from all patients adequately enrolled will be included in the analysis of results.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Patient provided written Informed Consent * Patient underwent mitral valve procedure (defined as mitral valve surgical intervention via endoscopic, mini thoracotomy, or full sternotomy approach, including mitral annuloplasty with a ring, resection of mitral valve leaflets, and replacement of mitral chordae tendineae) using the Chord-X System as clinically indicated (i.e. not off-label) by Principal Investigator at research site * Patient's Chord-X System implant occurred no earlier than January 1, 2022 * Patient is able and willing to participate in follow-up visits for the duration of the study (i.e. through 10 years post-op) Exclusion Criteria: * Patient was implanted with the Chord-X System off-label * Patient was implanted with the Chord-X System prior to January 1, 2022 * Patient has had previous mitral valve surgery * Patient underwent a multi valve repair procedure * Patient with an ejection fraction ≤ 50% at baseline * Patient underwent concomitant surgical procedures (except for maze procedure, PFO or LAA closure) at time of mitral repair procedure * Patient whose mitral valve procedure was performed as part of an emergency surgery (defined as a time period from diagnosis to surgery of ≤ 48 hours) * Patient with persistent or permanent atrial fibrillation * Patient with active or a history of endocarditis * Patient with congenital heart disease

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency

As listed by the trial registrant

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

Mitral regurgitation (MR)

How to take part

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

The places running it

4 sites in 3 countries. The list below names each one and where it is.
The official record

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

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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.

Heart valve repair device tracked for 10 years in new study

What the study statuses mean