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

NCT07413926 · tracked via the Priya Life Science UK tracker

Sponsor

Artivion Inc.

Phase

Observational

Started

2026-06

Last updated

2026-02-20

Condition(s) studied

Mitral Regurgitation (MR)

Investigational drug(s) / intervention(s)

Chord-X system implant

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

Study 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

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Recurrent Mitral Regurgitation — 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.

Trial sites (4)

Facility	City	Region
St. Elizabeth Healthcare	Edgewood	Kentucky
Monasterio Foundation Heart Hospital	Massa	Italy
Blackpool Victoria Hospital	Blackpool	United Kingdom
The James Cook University Hospital	Middlesbrough	United Kingdom

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07413926 on ClinicalTrials.gov ↗ ← All trials in the UK