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Long-Term Evaluation of the Chord-X System for Mitral Regurgitation

This study is looking at the long-term safety and performance of the Chord-X System, a device used during mitral valve repair surgery for people with mitral regurgitation (a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward). The Chord-X System helps replace damaged parts of the mitral valve. This is an observational study, meaning researchers will collect health information from patients who have already had this surgery since January 2022. The main goal is to see how well the Chord-X System prevents mitral regurgitation from returning over 10 years. This information will help improve care for future patients. The study is open to all adults who have had a mitral valve procedure using the Chord-X System and agree to share their medical history and follow-up exam results.

Study design
This is an observational study that plans to enroll 110 participants. It is not specified if the study is blinded or randomized.
What's involved
You would agree to the collection of your past medical history, details of your surgery with the Chord-X System, and results from your routine follow-up appointments.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years after their implant to evaluate recurrent mitral regurgitation.

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NCT07413926

Mitral Valve Repair With the Chord-X System: A Long Term Evaluation

Not Yet Recruiting
Not specifiedAll AgesObservational
Artivion Inc.
~110 participants
Updated 2026-02-20 on ClinicalTrials.gov
What's tested:Chord-X system implant

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrent Mitral Regurgitation
Measured over The primary endpoint will be evaluated at all time points in the study, through 10 years post-implant.

Conditions

Mitral Regurgitation (MR)

Explore related trials

Mitral Valve Insufficiency

Where it's being run

4 sites across 3 states
United Kingdom2
Kentucky1
Italy1

Study leadership

  • Joseph Zacharias, MD · PRINCIPAL_INVESTIGATOR

Who to contact

Priya Patel
[email protected]
16789843952
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Recurrent Mitral RegurgitationThe primary endpoint will be evaluated at all time points in the study, through 10 years post-implant.

    The primary endpoint of the study is recurrent moderate to severe (3+) mitral regurgitation (MR). Mitral regurgitation severity is classified as none/trivial (0), mild (1+), moderate (2+), moderate to severe (3+) or severe (4+). The wording moderate to severe is used to describe the upper end of the moderate range. The process of grading MR is comprehensive, using a combination of clues, signs and measurements obtained by Doppler echocardiography.