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

NCT07413926 | Not Yet Recruiting FDA Device

• 1 other identifier: CHX2401.000-M (08/24)
• Study Type: observational
• Target: 110
• Locations: 3 countries
• Sites: 4

Brief Summary

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

Conditions

Mitral Regurgitation (MR)

Keywords

mitral regurgitation; Chord-X

Outcome Measures

Primary Outcomes (1)

• Recurrent Mitral Regurgitation

  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.

Study Arms (1)

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

Interventions

Chord-X system implant DEVICE

Patients, who underwent a mitral valve procedure, using the Chord-X System as clinically indicated, whose surgery occurred beginning in January 2022

Patients who underwent mitral repair with Chord-X system beginning in January 2022

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Artivion Inc.: lead

Study Sites (4)

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

Location

Monasterio Foundation Heart Hospital

Massa, Italy

Location

Blackpool Victoria Hospital

Blackpool, United Kingdom

Location

The James Cook University Hospital

Middlesbrough, United Kingdom

Location

Related Publications (7)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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).

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• Gillinov M, Q. R. (2016). Premeasured Chordal Loops for Mitral Valve Repair. Ann Thorac Surg, 102:e269-e271.

  BACKGROUND

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Joseph Zacharias, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priya Patel

CONTACT

16789843952; priya.patel@artivion.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2034
• Study Completion (Estimated): June 1, 2034
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); GB (2); IT (1)