Mitral Valve Repair With the Chord-X System: A Long Term Evaluation
Starting soon
Conditions studied: Mitral Regurgitation (MR)
In brief
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
Key facts
- Study ID
- NCT07413926
- Run by
- Artivion Inc.
- People needed
- 110
- Starts
- 2026-06-01
- Expected to finish
- 2034-06-01
- Last updated by the study team
- 2026-02-20
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- St. Elizabeth Healthcare — Edgewood, Kentucky, United States
- Monasterio Foundation Heart Hospital — Massa, Italy
- Blackpool Victoria Hospital — Blackpool, United Kingdom
- The James Cook University Hospital — Middlesbrough, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.