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
This trial does not accept healthy volunteersQualifiers
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 population
In this study, all 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, approximately 3 years prior to enrollment (beginning in January 2022), will be approached for participation in the study. Approximately 110 patients will be enrolled at five medical centers in the UK, EU and the United States. To ensure balanced representation across centers, each center will be expected to enroll a minimum of 15 patients and a maximum of 30 patients. 110 patients are planned for enrollment with the possibility to recruit up to 10 more patients for a total of 120 patients. Data from all patients adequately enrolled will be included in the analysis of results.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Chord-X system implant
DevicePatients, who underwent a mitral valve procedure, using the Chord-X System as clinically indicated, whose surgery occurred beginning in January 2022
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: Patients who underwent mitral repair with Chord-X system beginning in January 20221 intervention
Trial outcomes
Primary outcomes
1
Recurrent Mitral Regurgitation
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.
Time frame
The primary endpoint will be evaluated at all time points in the study, through 10 years post-implant.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: