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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)