Follow-up on Abbott annuloplasty devices for heart valve repair
Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study
This study is testing how safe and effective Abbott annuloplasty devices are for repairing heart valves in adults who are having heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 17 sites (Durham, North Carolina and 16 other locations) |
| Trial ID | NCT04761120 on ClinicalTrials.gov |
What this trial studies
The ARB-PMCF study is a multicenter, observational study assessing the safety and performance of Abbott annuloplasty devices used in surgical repairs for mitral and tricuspid valve regurgitation. It involves enrolling up to 550 adult participants who are expected to undergo cardiac surgery within 90 days, with follow-up visits conducted annually for five years post-implant. The study aims to collect data on adverse events, medication usage, functional classification, and echocardiographic assessments to fulfill post-market clinical follow-up requirements in the EU. Participants will be grouped based on the type of annuloplasty device used and the nature of their valve disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for mitral or tricuspid valve repair surgery involving Abbott annuloplasty devices.
Not a fit: Patients who are not undergoing valve repair surgery or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the long-term safety and effectiveness of Abbott annuloplasty devices, potentially improving patient outcomes in valve repair surgeries.
How similar studies have performed: Other studies have shown success with similar annuloplasty devices, indicating a promising avenue for ongoing research in valve repair.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Durham, North Carolina and 16 other locations
- 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)
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Lombard, Italy (Recruiting)
- Ospedale Luigi Sacco — Milan, Milan, Italy (Withdrawn)
- Ospedale Umberto I — Turin, Piedmont, Italy (Recruiting)
- Catharina Ziekenhuis — Eindhoven, North Brabant, Netherlands (Recruiting)
- Hospital Alvaro Cunqueiro — Vigo, Pontevedra, Spain (Recruiting)
Study contacts
- Study coordinator: Karine Miquel
- Email: karine.miquel@abbott.com
- Phone: +32 479 60 01 07
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.