Actively Recruiting
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
Led by Abbott Medical Devices · Updated on 2025-07-09
550
Participants Needed
17
Research Sites
525 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled to undergo cardiac surgery within 90 days including implantation of an Abbott annuloplasty device for mitral or tricuspid valve repair
- Surgery will be performed by a study investigator
- Age 18 years or older at the time of annuloplasty implant
- Provides written informed consent and agrees to follow all study visits and procedures
You will not qualify if you...
- Below legal age for consent or lacks legal authority to provide informed consent
- Unable to read, write, or has mental illness or disability impairing consent ability
- Expected to have active endocarditis at time of device implant
- Cannot be clearly assigned to a treatment group due to missing device or repair data
- Participating in another clinical investigation or receiving treatment outside usual care
- Has anatomy, medical, surgical, psychiatric, or social conditions limiting study participation or follow-up compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Duke University Hospital
Durham, North Carolina, United States, 27710
Withdrawn
2
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Withdrawn
3
Tartu University Hospital
Tartu, Estonia, 50406
Actively Recruiting
4
Hopital Cardiovasculaire et Pneumologique Louis Pradel
Lyon, Auvergne-Rhône-Alpes, France, 69500
Actively Recruiting
5
CHU de Besançon - Jean Minjoz
Besançon, Bourgogne-Franche-Comté, France, 25000
Actively Recruiting
6
Herzchirurgische Abteilung Klinikum Passau
Passau, Bavaria, Germany, 94032
Actively Recruiting
7
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany, 97080
Completed
8
Herzzentrum-Bremen Klinikum Links der Weser
Bremen, Free Hanseatic City of Bremen, Germany, 28211
Actively Recruiting
9
Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
10
Universitätsklinikum Jena
Jena, Thuringia, Germany, 07740
Actively Recruiting
11
Policlinico S.Orsola-Malpighi
Bologna, Bologna, Italy, 40138
Actively Recruiting
12
Ospedale San Raffaele - Cardiac
Milan, Lombardy, Italy, 1350
Actively Recruiting
13
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombard, Italy, 20157
Actively Recruiting
14
Ospedale Luigi Sacco
Milan, Milan, Italy, 20157
Withdrawn
15
Ospedale Umberto I
Turin, Piedmont, Italy, 10128
Actively Recruiting
16
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands, 5623 EJ
Actively Recruiting
17
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain, 36312
Actively Recruiting
Research Team
K
Karine Miquel
CONTACT
L
Leslie Ornelas
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here