Recruiting
Observational
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
Condition(s) studied
Mitral RegurgitationTricuspid RegurgitationValvular Heart Disease
Investigational drug(s) / intervention(s)
Abbott SJM Rigid Saddle RingAbbott SJM Séguin RingAbbott SJM Tailor RingAbbott SJM Tailor Band
Abbott SJM Rigid Saddle Ring: The Abbott SJM Rigid Saddle Ring is a rigid, polyester-velour-covered, titanium alloy mitral annuloplasty ring with a saddle shape intended to mimic the shape of a healthy mitral annulus during systole.
Abbott SJM Séguin Ring: The Abbott SJM Séguin Ring is a semi-rigid, polyester-velour-covered, polyethylene mitral annuloplasty ring that varies in thickness and flexibility over its circumference, with the posterior portion of the ring having greater flexibility than the anterior portion.
Abbott SJM Tailor Ring: The Abbott SJM Tailor Ring is a flexible, polyester-velour-covered, silicone annuloplasty ring indicated for use in surgical repair of the mitral or tricuspid valve. The Tailor Ring can be implanted as a full annuloplasty ring, or the surgeon can remove the ring's cut zone with a scalpel and use the partial Tailor Ring as a posterior annuloplasty band.
Abbott SJM Tailor Band: The Abbott SJM Tailor Band is a flexible, polyester-velour-covered, silicone band for posterior annuloplasty indicated for use in surgical repair of mitral or tricuspid valve. The Tailor Band is identical to the Tailor Ring with the cut zone removed, save that the polyester covering is sewn closed at the ends of the band during manufacturing.
Study summary
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.
Eligibility
Inclusion Criteria:
1. Subject is expected to undergo cardiac surgery in ≤90 days including at least one of the following:
1. implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cut zone removal for MR repair
2. implant of a full Tailor Ring without cut zone removal for TR repair, or
3. implant of a Tailor Band or partial Tailor Ring with cut zone removed for primary TR repair.
2. Subject's cardiac surgery will be performed by a study investigator.
3. Subject will be ≥18 years old at the time of their annuloplasty implant(s).
4. Subject provides written informed consent and agrees to comply with all required study visits and procedures.
Exclusion Criteria:
1. Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent.
2. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.
3. Subject is expected to have active endocarditis at the time of their Abbott annuloplasty device implant(s).
4. Subject cannot be unambiguously assigned to a treatment group due to missing data on repair indication(s) or the model and configuration (cut zone removed or not) of their Abbott annuloplasty implant(s).
5. Subject is participating in another clinical investigation including any treatment outside the investigative site's usual standard of care.
6. Subject has anomalous anatomy or medical, surgical, psychiatric or social history or conditions that, in the investigator's opinion, would limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements
Primary outcome measure(s)
- Percentage of Participants in Each Treatment Group with Freedom from All-Cause Mortality through 5 Years Post-Implant — 5 years
Percentage of participants in each study treatment group (Groups 1 through 5) who are free of death from any cause through 5 years after their Abbott annuloplasty device implant, estimated from time-to-event data using the Kaplan-Meier estimator. This outcome will be reported for each treatment group separately.
- Percentage of Participants in Each Mitral Treatment Group with Freedom from Reoperation or Transcatheter Reintervention for Mitral Regurgitation through 5 Years Post-Implant — 5 years
Percentage of participants in each mitral treatment group (Groups 1 and 2) who are free from reoperation or transcatheter intervention for mitral regurgitation through 5 years after their Abbott annuloplasty implant, estimated from time-to-event data using the Kaplan-Meier estimator. This outcome will be reported separately for Group 1 and Group 2.
- Percentage of Participants in Each Tricuspid Treatment Group with at least a 1-Class Reduction in New York Heart Association (NYHA) Functional Classification at 1 Year Post-Implant. — 1 year
This outcome will be reported for each tricuspid repair group (Groups 3 through 5) separately. NYHA functional classification is a widely used indicator of the severity of heart failure symptoms with four classes:
Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath).
Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea.
Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Trial sites (17)
| Facility | City | Region | Status |
|---|
| Duke University Hospital |
Durham |
North Carolina |
Withdrawn |
| University of Wisconsin Hospital and Clinics |
Madison |
Wisconsin |
Withdrawn |
| Tartu University Hospital |
Tartu |
Estonia |
Recruiting |
| Hopital Cardiovasculaire et Pneumologique Louis Pradel |
Lyon |
Auvergne-Rhône-Alpes |
Recruiting |
| CHU de Besançon - Jean Minjoz |
Besançon |
Bourgogne-Franche-Comté |
Recruiting |
| Herzchirurgische Abteilung Klinikum Passau |
Passau |
Bavaria |
Recruiting |
| Universitätsklinikum Würzburg |
Würzburg |
Bavaria |
Completed |
| Herzzentrum-Bremen Klinikum Links der Weser |
Bremen |
Free Hanseatic City of Bremen |
Recruiting |
| Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden |
Dresden |
Saxony |
Recruiting |
| Universitätsklinikum Jena |
Jena |
Thuringia |
Recruiting |
| Policlinico S.Orsola-Malpighi |
Bologna |
Bologna |
Recruiting |
| Ospedale San Raffaele - Cardiac |
Milan |
Lombardy |
Recruiting |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico |
Milan |
Lombard |
Recruiting |
| Ospedale Luigi Sacco |
Milan |
Milan |
Withdrawn |
| Ospedale Umberto I |
Turin |
Piedmont |
Recruiting |
| Catharina Ziekenhuis |
Eindhoven |
North Brabant |
Recruiting |
| Hospital Alvaro Cunqueiro |
Vigo |
Pontevedra |
Recruiting |
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