Mitral Valve Repair With the Chord-X System: A Long Term Evaluation
ConditionMitral Regurgitation (MR)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorArtivion Inc.
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Chord-X system implant
Treatment groups
110 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov