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