Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04761120 · ClinicalTrials.gov registry record
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
A clinical trial of Mitral Regurgitation and Tricuspid Regurgitation, sponsored by Abbott Medical Devices.
- Recruiting
- Registry status
- 550
- Enrollment target
- 17
- Study locations
NCT04761120: Recruiting study of Mitral Regurgitation and Tricuspid Regurgitation, sponsored by Abbott Medical Devices.
NCT04761120 is a study of Mitral Regurgitation and Tricuspid Regurgitation that is actively recruiting participants, run by Abbott Medical Devices. The registered enrollment target is 550 participants, below the 1,003-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (45% lower). The trial reports 17 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04761120, a study of Mitral Regurgitation and Tricuspid Regurgitation, is actively recruiting participants, sponsored by Abbott Medical Devices.
- RECRUITING
- Registry status
- 550 participants
- Enrollment target
- 17
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Abbott SJM Rigid Saddle Ring
- DEVICE Abbott SJM Séguin Ring
- DEVICE Abbott SJM Tailor Ring
- DEVICE Abbott SJM Tailor Band
Study Locations (17)
Bavaria
- Herzchirurgische Abteilung Klinikum Passau - Passau
- Universitätsklinikum Würzburg - Würzburg
North Carolina
- Duke University Hospital - Durham
Wisconsin
- University of Wisconsin Hospital and Clinics - Madison
Other
- Tartu University Hospital - Tartu
Auvergne-Rhône-Alpes
- Hopital Cardiovasculaire et Pneumologique Louis Pradel - Lyon
Bourgogne-Franche-Comté
- CHU de Besançon - Jean Minjoz - Besançon
City state Bremen
- Herzzentrum-Bremen Klinikum Links der Weser - Bremen
Saxony
- Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden - Dresden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2031-03 |
What NCT04761120 shows while recruiting
NCT04761120 is an observational study that tracks outcomes without assigning an intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, below the 1,003-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (45% lower).
The record links to 3 conditions, with Mitral Regurgitation appearing as the primary indexed condition, and to 4 interventions - of which Abbott SJM Rigid Saddle Ring is the first listed.
NCT04761120 lists 17 locations in 16 states (Bavaria, North Carolina, Wisconsin).
Frequently Asked Questions
What is clinical trial NCT04761120 about?
NCT04761120 is a clinical study titled "Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study". 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 va...
What is the current status of trial NCT04761120?
This trial is currently recruiting. The enrollment target is 550 participants. The study started on 2021-02-01. Estimated completion is 2031-03.
What conditions does trial NCT04761120 study?
This clinical trial studies the following conditions: Mitral Regurgitation, Tricuspid Regurgitation, Valvular Heart Disease.
What interventions are being tested in trial NCT04761120?
The interventions under investigation include: Abbott SJM Rigid Saddle Ring (DEVICE), Abbott SJM Séguin Ring (DEVICE), Abbott SJM Tailor Ring (DEVICE), Abbott SJM Tailor Band (DEVICE).
Who is sponsoring clinical trial NCT04761120?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04761120 being conducted?
This trial has 17 study locations across North Carolina, Wisconsin, Auvergne-Rhône-Alpes, Bourgogne-Franche-Comté, Bavaria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mitral Regurgitation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04761120's enrollment target sits among peer trials
550 10th of 26 higher than 17 of 26 other Mitral Regurgitation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mitral Regurgitation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
RECRUITING · NA
-
The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
RECRUITING · NA
-
EFS of the CardioMech MVRS
RECRUITING · NA
-
Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease
RECRUITING
-
In Search of Best Practices for Patients With Heart Failure and Secondary Mitral Regurgitation: An Evaluation of the Inova Heart Failure Treatment Algorithm
RECRUITING
-
Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01852448 · 550 participants
Genetics of Insulin and Incretins in Cystic Fibrosis
- NCT02995252 · 550 participants
The HOPE Study: Characterizing Patients With Hepatitis B and C
- NCT03474913 · 550 participants
Upright MRI for Prostate Cancer Screening
- NCT04799535 · 550 participants
Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI