Actively Recruiting
Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study
Led by Abbott Medical Devices · Updated on 2026-05-18
550
Participants Needed
17
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing the safety and performance of Abbott annuloplasty devices used in surgeries to repair mitral and tricuspid valve regurgitation. This study includes devices such as the SJM Rigid Saddle Ring, SJM Séguin Annuloplasty Ring, SJM Tailor Annuloplasty Ring, and SJM Tailor Annuloplasty Band. The trial aims to meet post-market clinical follow-up requirements and follows up with participants for five years after their valve repair surgery. Participants will be grouped based on their specific valve condition and the device implanted during surgery. The five groups include primary and secondary mitral disease repairs using different annuloplasty rings, as well as primary and secondary tricuspid disease repairs using the Tailor Ring or Tailor Band. Enrollment occurs before surgery, and subjects will be implanted with one of these Abbott devices as part of their standard surgical care. After implantation, participants will complete yearly follow-up visits either in clinic or by phone for up to five years. Data collected will include any adverse events, use of cardiac medications, heart failure symptom severity measured by the New York Heart Association functional classification, and echocardiographic assessments of valve regurgitation. The study will measure outcomes such as survival rates, need for reoperation or reintervention, and improvement in heart function over time.
CONDITIONS
Brief Title
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Expected to undergo cardiac surgery within 90 days including implant of an Abbott annuloplasty device for mitral or tricuspid valve repair
- Surgery will be performed by a study investigator
- At least 18 years old at the time of annuloplasty implant
- Provides written informed consent and agrees to follow study visits and procedures
You will not qualify if you...
- Below legal age of consent or lacks legal authority to provide 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 repair or device data
- Participating in another clinical investigation with treatments outside usual care
- Has anatomy or medical, surgical, psychiatric, or social conditions limiting participation or follow-up compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 90 days before surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - 1 day
Participants undergo cardiac surgery to implant an Abbott annuloplasty device for mitral or tricuspid valve repair.
1 surgical visit (in-person)
Duration - 5 years from implant
Participants complete annual in-clinic or telephone follow-up visits to monitor heart function, adverse events, medication use, and valve performance.
Annual follow-up visits (in-clinic or telephone) for up to 5 years
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
L
Leslie Ornelas
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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