[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624768":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":88,"collaborators":10,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":10,"maxAge":10,"enrollmentInfo":98,"targetDuration":101,"studyType":102,"phases":10,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":109,"whyStopped":10,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Artivion Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients who underwent mitral repair with Chord-X system beginning in January 2022",null,"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, beginning in January 2022, will be approached for participation in the study.",[13],"Device: Chord-X system implant",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","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",[9],[21],{"name":22,"affiliation":10,"role":23},"Joseph Zacharias, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Priya Patel","CONTACT","16789843952","priya.patel@artivion.com",[31,48,62,76],{"facility":32,"status":10,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"St. Elizabeth Healthcare","Edgewood","Kentucky","41017","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-84.58189,39.01867,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":10,"phoneExt":10,"email":47},"Cynthia Mulcahy","Cynthia.Mulcahy@stelizabeth.com",{"facility":49,"status":10,"city":50,"state":10,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"Monasterio Foundation Heart Hospital","Massa","Italy","IT",{"type":39,"coordinates":54},[55,56],10.13927,44.03541,{"lat":56,"lon":55},[59],{"name":60,"role":27,"phone":10,"phoneExt":10,"email":61},"Alessandra Parlanti","alessandra.parlanti@ftgm.it",{"facility":63,"status":10,"city":64,"state":10,"zip":10,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Blackpool Victoria Hospital","Blackpool","United Kingdom","UK",{"type":39,"coordinates":68},[69,70],-3.05,53.81667,{"lat":70,"lon":69},[73],{"name":74,"role":27,"phone":10,"phoneExt":10,"email":75},"Vasanthi Vasudevan","vasanthi.vasudevan@nhs.net",{"facility":77,"status":10,"city":78,"state":10,"zip":10,"country":65,"countryCode":66,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"The James Cook University Hospital","Middlesbrough",{"type":39,"coordinates":80},[81,82],-1.23483,54.57623,{"lat":82,"lon":81},[85],{"name":86,"role":27,"phone":10,"phoneExt":10,"email":87},"Carmen Neave","carmen.neave@nhs.net",{"type":89,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100624768","mitral-valve-repair-with-the-chord-x-system-a-long-term-evaluation-100624768",false,"NCT07413926","Mitral Valve Repair With the Chord-X System: A Long Term Evaluation","METRIX","Inclusion Criteria:\n\n* Patient provided written Informed Consent\n* 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\n* Patient's Chord-X System implant occurred no earlier than January 1, 2022\n* Patient is able and willing to participate in follow-up visits for the duration of the study (i.e. through 10 years post-op)\n\nExclusion Criteria:\n\n* Patient was implanted with the Chord-X System off-label\n* Patient was implanted with the Chord-X System prior to January 1, 2022\n* Patient has had previous mitral valve surgery\n* Patient underwent a multi valve repair procedure\n* Patient with an ejection fraction ≤ 50% at baseline\n* Patient underwent concomitant surgical procedures (except for maze procedure, PFO or LAA closure) at time of mitral repair procedure\n* Patient whose mitral valve procedure was performed as part of an emergency surgery (defined as a time period from diagnosis to surgery of ≤ 48 hours)\n* Patient with persistent or permanent atrial fibrillation\n* Patient with active or a history of endocarditis\n* Patient with congenital heart disease","ALL",{"count":99,"type":100},110,"ESTIMATED","10 Years","OBSERVATIONAL","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.\n\nParticipants will:\n\nAgree 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",[105],"Mitral Regurgitation (MR)",[107,108],"mitral regurgitation","Chord-X","NOT_YET_RECRUITING","2026-02-18",{"date":112,"type":113},"2026-02-20","ACTUAL",{"date":115,"type":100},"2026-06",{"date":117,"type":100},"2034-06",{"name":5,"class":6},4]