Condition: Mitral Regurgitation · Tricuspid Regurgitation · Valvular Heart Disease · Sponsor: Abbott Medical Devices
ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.
This description comes directly from the study's public registry record.
Karine Miquel · +32 479 60 01 07 · karine.miquel@abbott.com
Leslie Ornelas · +14803067436 · leslie.ornelas@abbott.com
Always discuss trial participation with your own doctor first.
| Duke University Hospital | Durham, North Carolina, United States | Withdrawn |
| University of Wisconsin Hospital and Clinics | Madison, Wisconsin, United States | Withdrawn |
| Tartu University Hospital | Tartu, Estonia | Recruiting |
| Hopital Cardiovasculaire et Pneumologique Louis Pradel | Lyon, Auvergne-Rhône-Alpes, France | Recruiting |
| CHU de Besançon - Jean Minjoz | Besançon, Bourgogne-Franche-Comté, France | Recruiting |
| Herzchirurgische Abteilung Klinikum Passau | Passau, Bavaria, Germany | Recruiting |
| Universitätsklinikum Würzburg | Würzburg, Bavaria, Germany | Completed |
| Herzzentrum-Bremen Klinikum Links der Weser | Bremen, Free Hanseatic City of Bremen, Germany | Recruiting |
| Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden | Dresden, Saxony, Germany | Recruiting |
| Universitätsklinikum Jena | Jena, Thuringia, Germany | Recruiting |
| Policlinico S.Orsola-Malpighi | Bologna, Bologna, Italy | Recruiting |
| Ospedale San Raffaele - Cardiac | Milan, Lombardy, Italy | Recruiting |
+ 5 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04761120