Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study (NCT04761120)
Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Duke University Hospital — Durham, North Carolina
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- Duke University Hospital — Durham, North Carolina
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin
- Tartu University Hospital — Tartu,
- Hopital Cardiovasculaire et Pneumologique Louis Pradel — Lyon, Auvergne-Rhône-Alpes
- CHU de Besançon - Jean Minjoz — Besançon, Bourgogne-Franche-Comté
- Herzchirurgische Abteilung Klinikum Passau — Passau, Bavaria
- Universitätsklinikum Würzburg — Würzburg, Bavaria
- Herzzentrum-Bremen Klinikum Links der Weser — Bremen, Free Hanseatic City of Bremen
- Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden — Dresden, Saxony
- Universitätsklinikum Jena — Jena, Thuringia
- Policlinico S.Orsola-Malpighi — Bologna, Bologna
- Ospedale San Raffaele - Cardiac — Milan, Lombardy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Lombard
- Ospedale Luigi Sacco — Milan, Milan
- Ospedale Umberto I — Turin, Piedmont
- Catharina Ziekenhuis — Eindhoven, North Brabant
- Hospital Alvaro Cunqueiro — Vigo, Pontevedra
📞 Contact the Study Coordinator
Phone: +32 479 60 01 07
Email: karine.miquel@abbott.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Mitral Regurgitation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.