Mitral Valve Repair With the Chord-X System: A Long Term Evaluation
Artivion Inc.
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
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., r…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceChord-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
Locations (4)
- St. Elizabeth HealthcareEdgewood, Kentucky
- Monasterio Foundation Heart HospitalMassa
- Blackpool Victoria HospitalBlackpool
- The James Cook University HospitalMiddlesbrough