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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04761120
The ClinicalTrials.gov registry entry for NCT04761120 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 550 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,003-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (45% lower). The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
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 reports 17 study locations spanning 16 distinct geographic areas - top geographies include 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.
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