Mitral RegurgitationARB-PMCFNCT04761120
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
An observational study of Mitral Regurgitation and Tricuspid Regurgitation, run by Abbott Medical Devices at 17 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Tricuspid Regurgitation, Valvular Heart Disease
- What is being tested?
- Abbott SJM Rigid Saddle Ring, Abbott SJM Séguin Ring and Abbott SJM Tailor Ring
- Type of treatment
- Medical device
- How many people
- 550 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 1 Feb 2021to Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll male and female adult subjects from the general population of cardiac surgery patients who are expected to be implanted with a Rigid Saddle, Séguin or full Tailor Ring for mitral regurgitation (MR) repair, a full Tailor Ring for tricuspid regurgitation (TR) repair or a Tailor Band or partial Tailor Ring for primary TR repair within 90 days.
Who may be able to join
- Subject is expected to undergo cardiac surgery in ≤90 days including at least one of the following:
- implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cut zone removal for MR repair
- implant of a full Tailor Ring without cut zone removal for TR repair, or
- implant of a Tailor Band or partial Tailor Ring with cut zone removed for primary TR repair.
- Subject's cardiac surgery will be performed by a study investigator.
- Subject will be ≥18 years old at the time of their annuloplasty implant(s).
- Subject provides written informed consent and agrees to comply with all required study visits and procedures.
Who cannot join
- Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent.
- Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.
- Subject is expected to have active endocarditis at the time of their Abbott annuloplasty device implant(s).
- 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).
- Subject is participating in another clinical investigation including any treatment outside the investigative site's usual standard of care.
- 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
Trial locations and contacts
17 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 7 countries
Germany5 sites, 4 recruiting
- Recruiting
Herzzentrum-Bremen Klinikum Links der Weser
Bremen, Free Hanseatic City of Bremen, 28211
Dr Thorsten Schmidt, MD
- Recruiting
Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
Dresden, Saxony, 01307
Prof. Dr. Klaus Matschke, MD, PhD
- Recruiting
Universitätsklinikum Jena
Jena, Thuringia, 07740
Prof. Dr. Torsten Doenst, MD, PhD
- Recruiting
Herzchirurgische Abteilung Klinikum Passau
Passau, Bavaria, 94032
Dr. Markus Czesla, MD
- Completed
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080
Italy5 sites, 4 recruiting
- Recruiting
Policlinico S.Orsola-Malpighi
Bologna, Bologna, 40138
Prof Davide Pacini, MD
- Recruiting
Ospedale San Raffaele - Cardiac
Milan, Lombardy, 1350
Prof. Michele De Bonis, MD
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombard, 20157
Prof Carlo Antona, MDA
- Withdrawn
Ospedale Luigi Sacco
Milan, Milan, 20157
- Recruiting
Ospedale Umberto I
Turin, Piedmont, 10128
Dr Paolo Centofanti, MD
United States2 sites
- Withdrawn
Duke University Hospital
Durham, North Carolina, 27710
- Withdrawn
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
France2 sites, 2 recruiting
- Recruiting
CHU de Besançon - Jean Minjoz
Besançon, Bourgogne-Franche-Comté, 25000
Dr Sidney Chocron, MD
- Recruiting
Hopital Cardiovasculaire et Pneumologique Louis Pradel
Lyon, Auvergne-Rhône-Alpes, 69500
Prof Jean-François Obadia, MD
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital
Tartu, 50406
Prof Arno Ruusalepp, PhD
Netherlands1 site, 1 recruiting
- Recruiting
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623 EJ
Dr Andrew Tjon, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, 36312
Dr Juan José Legarra, MD
About this study
Official title: Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) 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 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.
Read the detailed description
The ARB-PMCF Study has a prospective, multicenter, observational, parallel group design in which up to 550 subjects will be followed through five years from implant of an Abbott annuloplasty device, with or without concomitant procedures, in five treatment groups, including primary mitral disease repair (N=200) with the Rigid Saddle Ring, Séguin Ring or full Tailor Ring without cut zone removal; secondary mitral disease repair (N=200) with the Rigid Saddle Ring, Séguin Ring or full Tailor Ring; primary tricuspid disease repair with the full Tailor Ring (N=50); secondary tricuspid disease repair with the full Tailor Ring (N=50); and primary tricuspid disease repair with the Tailor Band or partial Tailor Ring with cut zone removed (N=50). Study enrollment will occur at up to 25 global centers with approximately half or more of all implanted subjects being from European sites. The study will enroll adult subjects expected to be implanted with an Abbott annuloplasty device within 90 days who meet all other eligibility requirements. Participants will complete annual in-clinic or telephone follow-up visits through five years from their annuloplasty implant. Data collected will include adverse events, cardiac medication usage, New York Heart Association functional classification (a measure of the severity of heart failure symptoms) and echocardiographic assessments of regurgitation through the repaired valve.
- Being tested
- Abbott SJM Rigid Saddle Ring, Abbott SJM Séguin Ring, Abbott SJM Tailor Ring, Abbott SJM Tailor Band
- Keywords
- Mitral Regurgitation, Tricuspid Regurgitation, Valve Surgery, Valve Repair, Annuloplasty Rings, Annuloplasty Bands, Rigid Saddle Ring, Séguin Annuloplasty Ring, Tailor Annuloplasty Ring, Tailor Annuloplasty Band
- Medical subject headings
- Mitral Valve Insufficiency, Tricuspid Valve Insufficiency, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott SJM Rigid Saddle RingDevice
The Abbott SJM Rigid Saddle Ring is a rigid, polyester-velour-covered, titanium alloy mitral annuloplasty ring with a saddle shape intended to mimic the shape of a healthy mitral annulus during systole.
Abbott SJM Séguin RingDevice
The Abbott SJM Séguin Ring is a semi-rigid, polyester-velour-covered, polyethylene mitral annuloplasty ring that varies in thickness and flexibility over its circumference, with the posterior portion of the ring having greater flexibility than the anterior portion.
Abbott SJM Tailor RingDevice
The Abbott SJM Tailor Ring is a flexible, polyester-velour-covered, silicone annuloplasty ring indicated for use in surgical repair of the mitral or tricuspid valve. The Tailor Ring can be implanted as a full annuloplasty ring, or the surgeon can remove the ring's cut zone with a scalpel and use the partial Tailor Ring as a posterior annuloplasty band.
Abbott SJM Tailor BandDevice
The Abbott SJM Tailor Band is a flexible, polyester-velour-covered, silicone band for posterior annuloplasty indicated for use in surgical repair of mitral or tricuspid valve. The Tailor Band is identical to the Tailor Ring with the cut zone removed, save that the polyester covering is sewn closed at the ends of the band during manufacturing.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Primary mitral disease repair surgery with an Abbott annuloplasty ring implant | Group 1 will enroll 200 subjects undergoing surgical repair of primary mitral regurgitation that includes annuloplasty with an Abbott SJM Rigid Saddle Ring, Séguin Ring or full Tailor Ring without cut zone removal. Enrollment must include at least 50 subjects implanted with each ring model. In primary mitral regurgitation, backflow through the closed valve is caused by disease intrinsic to the mitral valve tissue itself. Receives: Device: Abbott SJM Rigid Saddle Ring; Device: Abbott SJM Séguin Ring; Device: Abbott SJM Tailor Ring | |
| Group 2: Secondary mitral disease repair surgery with an Abbott annuloplasty ring implant | Group 2 will enroll 200 subjects undergoing surgical repair of secondary mitral regurgitation that includes annuloplasty with an Abbott SJM Rigid Saddle Ring, Séguin Ring or full Tailor Ring without cut zone removal. Enrollment must include at least 50 subjects implanted with each ring model. In secondary mitral regurgitation, backflow through the closed valve is secondary to diseases of the surrounding myocardium, rather than caused by disease of the valve tissue itself. Receives: Device: Abbott SJM Rigid Saddle Ring; Device: Abbott SJM Séguin Ring; Device: Abbott SJM Tailor Ring | |
| Group 3: Primary tricuspid disease repair surgery with a full Tailor Ring implant | Group 3 will enroll up to 50 subjects undergoing surgical repair of primary tricuspid regurgitation that includes annuloplasty with a full Abbott SJM Tailor Ring without cut zone removal. In primary tricuspid regurgitation, backflow through the closed valve is caused by disease intrinsic to the tricuspid valve tissue itself. Receives: Device: Abbott SJM Tailor Ring | |
| Group 4: Secondary tricuspid disease repair surgery with a full Tailor Ring implant | Group 4 will enroll up to 50 subjects undergoing surgical repair of secondary tricuspid regurgitation that includes annuloplasty with a full Abbott SJM Tailor Ring without cut zone removal. In secondary tricuspid regurgitation, backflow through the closed valve is secondary to diseases of the surrounding myocardium, rather than caused by disease of the valve tissue itself. Receives: Device: Abbott SJM Tailor Ring | |
| Group 5: Primary tricuspid disease repair surgery with a partial Tailor Ring or Tailor Band implant | Group 4 will enroll up to 50 subjects undergoing surgical repair of secondary tricuspid regurgitation that includes posterior annuloplasty with either a partial Abbott SJM Tailor Ring with cut zone removed or an Abbott SJM Tailor Band. In primary tricuspid regurgitation, backflow through the closed valve is caused by disease intrinsic to the tricuspid valve tissue itself. Receives: Device: Abbott SJM Tailor Ring; Device: Abbott SJM Tailor Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants in Each Treatment Group with Freedom from All-Cause Mortality through 5 Years Post-Implant
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.
Measured: 5 years
Percentage of Participants in Each Mitral Treatment Group with Freedom from Reoperation or Transcatheter Reintervention for Mitral Regurgitation through 5 Years Post-Implant
Percentage of participants in each mitral treatment group (Groups 1 and 2) who are free from reoperation or transcatheter intervention for mitral regurgitation through 5 years after their Abbott annuloplasty implant, estimated from time-to-event data using the Kaplan-Meier estimator. This outcome will be reported separately for Group 1 and Group 2.
Measured: 5 years
Percentage of Participants in Each Tricuspid Treatment Group with at least a 1-Class Reduction in New York Heart Association (NYHA) Functional Classification at 1 Year Post-Implant.
This outcome will be reported for each tricuspid repair group (Groups 3 through 5) separately. NYHA functional classification is a widely used indicator of the severity of heart failure symptoms with four classes:
Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath).
Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea.
Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Measured: 1 year
Secondary outcomes (2)
Number of Participants in Each Treatment Group by Grade of Regurgitation in the Valve Undergoing Repair, Pre-Operatively, at Discharge, and at 1, 3 and 5 Years Post-Implant
This outcome will be reported for each treatment group separately at each timepoint. Regurgitation occurs when a heart valve does not fully seal, allowing backflow of blood through the closed valve. Mitral and tricuspid valve regurgitation in this study will be graded as none/trivial, mild, moderate or severe by echocardiographic assessment. Moderate or severe regurgitation can cause symptoms of heart failure, such as fatigue, shortness of breath and exercise intolerance.
Measured: Pre-Operative Baseline, within 60 days post-implant, and 1, 3 and 5 years post-implant
Number of Participants in Each Treatment Group by NYHA Functional Class, Pre-Operatively and at Discharge, 1, 3 and 5 Years Post-Implant.
This outcome will be reported for each treatment group separately at each timepoint. NYHA functional classification is a widely used indicator of the severity of heart failure symptoms with four classes:
Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath).
Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea.
Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Measured: Pre-Operative Baseline, within 60 days post-implant, and 1, 3 and 5 years post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Feb 2021
- Primary completionNov 2030 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Palmer, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761120
- Sponsor's protocol ID
- ABT-CIP-10368
- Acronym
- ARB-PMCF
- Status last verified
- May 2026
- First submitted
- 12 Feb 2021
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study
- ClinicalTrials.gov ID
- NCT04761120
- Acronym / sponsor ID
- ARB-PMCF / ABT-CIP-10368
- Keywords
- Mitral Regurgitation, Tricuspid Regurgitation, Valve Surgery, Valve Repair, Annuloplasty Rings, Annuloplasty Bands, Rigid Saddle Ring, Séguin Annuloplasty Ring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The ARB-PMCF Study has a prospective, multicenter, observational, parallel group design in which up to 550 subjects will be followed through five years from implant of an Abbott annuloplasty device, with or without concomitant procedures, in five treatment groups, including primary mitral disease repair (N=200) with the Rigid Saddle Ring, Séguin Ring or full Tailor Ring without cut zone removal; secondary mitral disease repair (N=200) with the Rigid Saddle Ring, Séguin Ring or full Tailor Ring; primary tricuspid disease repair with the full Tailor Ring (N=50); secondary tricuspid disease repair with the full Tailor Ring (N=50); and primary tricuspid disease repair with the Tailor Band or partial Tailor Ring with cut zone removed (N=50). Study enrollment will occur at up to 25 global centers with approximately half or more of all implanted subjects being from European sites. The study will enroll adult subjects expected to be implanted with an Abbott annuloplasty device within 90 days who meet all other eligibility requirements. Participants will complete annual in-clinic or telephone follow-up visits through five years from their annuloplasty implant. Data collected will include adverse events, cardiac medication usage, New York Heart Association functional classification (a measure of the severity of heart failure symptoms) and echocardiographic assessments of regurgitation through the repaired valve.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: Primary mitral disease repair surgery with an Abbott annuloplasty ring implant | – | Device: Abbott SJM Rigid Saddle Ring, Device: Abbott SJM Séguin Ring, Device: Abbott SJM Tailor RingGroup 1 will enroll 200 subjects undergoing surgical repair of primary mitral regurgitation that includes annuloplasty with an Abbott SJM Rigid Saddle Ring, Séguin Ring or full Tailor Ring without cut zone removal. Enrollment must include at least 50 subjects implanted with each ring model. In primary mitral regurgitation, backflow through the closed valve is caused by disease intrinsic to the mitral valve tissue itself. |
| Group 2: Secondary mitral disease repair surgery with an Abbott annuloplasty ring implant | – | Device: Abbott SJM Rigid Saddle Ring, Device: Abbott SJM Séguin Ring, Device: Abbott SJM Tailor RingGroup 2 will enroll 200 subjects undergoing surgical repair of secondary mitral regurgitation that includes annuloplasty with an Abbott SJM Rigid Saddle Ring, Séguin Ring or full Tailor Ring without cut zone removal. Enrollment must include at least 50 subjects implanted with each ring model. In secondary mitral regurgitation, backflow through the closed valve is secondary to diseases of the surrounding myocardium, rather than caused by disease of the valve tissue itself. |
| Group 3: Primary tricuspid disease repair surgery with a full Tailor Ring implant | – | Device: Abbott SJM Tailor RingGroup 3 will enroll up to 50 subjects undergoing surgical repair of primary tricuspid regurgitation that includes annuloplasty with a full Abbott SJM Tailor Ring without cut zone removal. In primary tricuspid regurgitation, backflow through the closed valve is caused by disease intrinsic to the tricuspid valve tissue itself. |
| Group 4: Secondary tricuspid disease repair surgery with a full Tailor Ring implant | – | Device: Abbott SJM Tailor RingGroup 4 will enroll up to 50 subjects undergoing surgical repair of secondary tricuspid regurgitation that includes annuloplasty with a full Abbott SJM Tailor Ring without cut zone removal. In secondary tricuspid regurgitation, backflow through the closed valve is secondary to diseases of the surrounding myocardium, rather than caused by disease of the valve tissue itself. |
| Group 5: Primary tricuspid disease repair surgery with a partial Tailor Ring or Tailor Band implant | – | Device: Abbott SJM Tailor Ring, Device: Abbott SJM Tailor BandGroup 4 will enroll up to 50 subjects undergoing surgical repair of secondary tricuspid regurgitation that includes posterior annuloplasty with either a partial Abbott SJM Tailor Ring with cut zone removed or an Abbott SJM Tailor Band. In primary tricuspid regurgitation, backflow through the closed valve is caused by disease intrinsic to the tricuspid valve tissue itself. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll male and female adult subjects from the general population of cardiac surgery patients who are expected to be implanted with a Rigid Saddle, Séguin or full Tailor Ring for mitral regurgitation (MR) repair, a full Tailor Ring for tricuspid regurgitation (TR) repair or a Tailor Band or partial Tailor Ring for primary TR repair within 90 days.
Key inclusion criteria (7 listed)
- Subject is expected to undergo cardiac surgery in ≤90 days including at least one of the following:
- Subject's cardiac surgery will be performed by a study investigator.
- Subject will be ≥18 years old at the time of their annuloplasty implant(s).
- Subject provides written informed consent and agrees to comply with all required study visits and procedures.
Key exclusion criteria (6 listed)
- Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent.
- Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent.
- Subject is expected to have active endocarditis at the time of their Abbott annuloplasty device implant(s).
- 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).
- Subject is participating in another clinical investigation including any treatment outside the investigative site's usual standard of care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbott SJM Rigid Saddle RingThe Abbott SJM Rigid Saddle Ring is a rigid, polyester-velour-covered, titanium alloy mitral annuloplasty ring with a saddle shape intended to mimic the shape of a healthy mitral annulus during systole. | Device | Group 1: Primary mitral disease repair surgery with an Abbott annuloplasty ring implant, Group 2: Secondary mitral disease repair surgery with an Abbott annuloplasty ring implant |
| Abbott SJM Séguin RingThe Abbott SJM Séguin Ring is a semi-rigid, polyester-velour-covered, polyethylene mitral annuloplasty ring that varies in thickness and flexibility over its circumference, with the posterior portion of the ring having greater flexibility than the anterior portion. | Device | Group 1: Primary mitral disease repair surgery with an Abbott annuloplasty ring implant, Group 2: Secondary mitral disease repair surgery with an Abbott annuloplasty ring implant |
| Abbott SJM Tailor RingThe Abbott SJM Tailor Ring is a flexible, polyester-velour-covered, silicone annuloplasty ring indicated for use in surgical repair of the mitral or tricuspid valve. The Tailor Ring can be implanted as a full annuloplasty ring, or the surgeon can remove the ring's cut zone with a scalpel and use the partial Tailor Ring as a posterior annuloplasty band. | Device | Group 1: Primary mitral disease repair surgery with an Abbott annuloplasty ring implant, Group 2: Secondary mitral disease repair surgery with an Abbott annuloplasty ring implant, Group 3: Primary tricuspid disease repair surgery with a full Tailor Ring implant, Group 4: Secondary tricuspid disease repair surgery with a full Tailor Ring implant, Group 5: Primary tricuspid disease repair surgery with a partial Tailor Ring or Tailor Band implant |
| Abbott SJM Tailor BandThe Abbott SJM Tailor Band is a flexible, polyester-velour-covered, silicone band for posterior annuloplasty indicated for use in surgical repair of mitral or tricuspid valve. The Tailor Band is identical to the Tailor Ring with the cut zone removed, save that the polyester covering is sewn closed at the ends of the band during manufacturing. | Device | Group 5: Primary tricuspid disease repair surgery with a partial Tailor Ring or Tailor Band implant |
Primary outcome
Percentage of Participants in Each Treatment Group with Freedom from All-Cause Mortality through 5 Years Post-Implant
Time frame: 5 years
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.
Percentage of Participants in Each Mitral Treatment Group with Freedom from Reoperation or Transcatheter Reintervention for Mitral Regurgitation through 5 Years Post-Implant
Time frame: 5 years
Percentage of participants in each mitral treatment group (Groups 1 and 2) who are free from reoperation or transcatheter intervention for mitral regurgitation through 5 years after their Abbott annuloplasty implant, estimated from time-to-event data using the Kaplan-Meier estimator. This outcome will be reported separately for Group 1 and Group 2.
Percentage of Participants in Each Tricuspid Treatment Group with at least a 1-Class Reduction in New York Heart Association (NYHA) Functional Classification at 1 Year Post-Implant.
Time frame: 1 year
This outcome will be reported for each tricuspid repair group (Groups 3 through 5) separately. NYHA functional classification is a widely used indicator of the severity of heart failure symptoms with four classes: Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
2 secondary outcomes
Number of Participants in Each Treatment Group by Grade of Regurgitation in the Valve Undergoing Repair, Pre-Operatively, at Discharge, and at 1, 3 and 5 Years Post-Implant
Time frame: Pre-Operative Baseline, within 60 days post-implant, and 1, 3 and 5 years post-implant
Number of Participants in Each Treatment Group by NYHA Functional Class, Pre-Operatively and at Discharge, 1, 3 and 5 Years Post-Implant.
Time frame: Pre-Operative Baseline, within 60 days post-implant, and 1, 3 and 5 years post-implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan Palmer study director
Abbott
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation and Tricuspid Regurgitation, run by Abbott Medical Devices at 17 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Italy, United States, France, Estonia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karine Miquel (+32 479 60 01 07, karine.miquel@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants in Each Treatment Group with Freedom from All-Cause Mortality through 5 Years Post-Implant (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.