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

February 18, 2026 updated by: Artivion Inc.

The goal of this clinical trial is to strengthen the evidence available for the Chord-X System by collecting follow-up data from patients who underwent Chord-X implant and to evaluate the long-term safety and performance data (out to 10 years). Collecting patient health information over time can help to supplement and improve the care of patients in the future.

Participants will:

Agree to the collection of their past medical history, and the details of their mitral repair surgery with the Chord-X system, including results of the follow-up examinations after implantation Visit the clinic for the routinely scheduled follow-up examination appointments

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The Chord-X Mitral Chordal Replacement System (Chord-X System) is indicated for the treatment of patients with mitral regurgitation who are not at high surgical risk as judged by a multidisciplinary heart team. It is a premade artificial suture system comprised of the Chord-X Adjustable Sutures or Chord-X Pre-Measured Loops, and Chord-X® Chordal Sizer. The Chord-X Suture System or Chord-X Pre-Measured Loops are intended to replace the chordae tendinae during a surgical mitral valve repair procedure to treat patients with mitral regurgitation due to defective native mitral valve chords (i.e., ruptured or elongated native chords). The Choral Sizer is intended to assist the surgeon in determining the length of the chordal tendinae to be replaced, for selection of the Chord-X loop size (pre-measured or adjusted). The Chord-X System is intended for use by trained cardiac surgeons with experience in performing mitral valve repair procedures.

The study is initiated to strengthen the body of evidence available for the Chord-X System by collecting follow-up data from patients who underwent Chord-X implant, to evaluate long-term (10 years) clinical benefit, safety, and performance data from use in the real-world setting.

This is a multicenter, single arm, retrospective & prospective study collecting anonymized data from past and future records of patients who meet the following patient population criteria: 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 per the standard of care, at a high-volume center, whose surgery occurred beginning in January 2022 (approximately 3 years prior to enrolment).

110 patients (+ up to 10 patients) will be enrolled in up to five clinical centers.

The primary study endpoint is recurrent moderate to severe (3+) mitral regurgitation. Secondary endpoints are all cause mortality and reoperation for recurrent mitral regurgitation.

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. If there are signs suggesting that MR is more than mild, quantitative methods (including mean gradient and ejection fraction) are used to determine the degree of MR .

This study involves a hybrid (retrospective and prospective) data collection from patients who have already been implanted with the Chord-X System. It is a multicenter, international, open label registry collecting real-world data from patients who underwent endoscopic or sternotomy mitral valve repair using the Chord-X System, as clinically indicated, approximately 3 years prior to enrolment (beginning in January 2022).

Study Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who underwent mitral repair with Chord-X system beginning in January 2022
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, beginning in January 2022, will be approached for participation in the study.
Device: Chord-X system implant
Patients, who underwent a mitral valve procedure, using the Chord-X System as clinically indicated, whose surgery occurred beginning in January 2022

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent Mitral Regurgitation
Time Frame: The 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.
The primary endpoint will be evaluated at all time points in the study, through 10 years post-implant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Artivion Inc.

Investigators

  • Principal Investigator: Joseph Zacharias, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Lang M, Vitanova K, Voss B, Feirer N, Rheude T, Krane M, Gunther T, Lange R. Beyond the 10-Year Horizon: Mitral Valve Repair Solely With Chordal Replacement and Anuuloplasty. The Society of Thoracic Surgeons 2023;115:96-105. https://doi.org/10.1016/j.athoracsur.2022.05.036.
  • Stone GW, et al.; Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium. Eur Heart J. 2015 Aug 1;36(29):1878-91.
  • Figlioli G, Sticchi A, Christodoulou MN, et al. Global Prevalence of Mitral Regurgitation: A Systematic Review and Meta-Analysis of Population-Based Studies. J Clin Med. 2025;14(8).
  • Zoghbi WA, Adams D, Bonow RO, et al. Recommendations for noninvasive evaluation of native valvular regurgitation: a report from the American Society of Echocardiography developed in collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017;30:303-371.
  • Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022;43(7):561-632.
  • El Sabbagh A, Reddy YNV, Nishimura RA. Mitral Valve Regurgitation in the Contemporary Era: Insights Into Diagnosis, Management, and Future Directions. JACC Cardiovasc Imaging. 2018;11(4):628-643
  • Gillinov M, Q. R. (2016). Premeasured Chordal Loops for Mitral Valve Repair. Ann Thorac Surg, 102:e269-e271.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2034

Study Completion (Estimated)

June 1, 2034

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHX2401.000-M (08/24)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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