- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04761120
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study (ARB-PMCF)
Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Karine Miquel
- Phone Number: +32 479 60 01 07
- Email: karine.miquel@abbott.com
Study Contact Backup
- Name: Leslie Ornelas
- Phone Number: +14803067436
- Email: leslie.ornelas@abbott.com
Study Locations
-
-
-
Tartu, Estonia, 50406
- Recruiting
- Tartu University Hospital
-
Contact:
- Prof Arno Ruusalepp, PhD
-
-
-
-
Auvergne-Rhône-Alpes
-
Lyon, Auvergne-Rhône-Alpes, France, 69500
- Recruiting
- Hopital Cardiovasculaire et Pneumologique Louis Pradel
-
Contact:
- Prof Jean-François Obadia, MD
-
-
Bourgogne-Franche-Comté
-
Besançon, Bourgogne-Franche-Comté, France, 25000
- Recruiting
- CHU de Besançon - Jean Minjoz
-
Contact:
- Dr Sidney Chocron, MD
-
-
-
-
-
Bremen, Germany, 28211
- Recruiting
- Herzzentrum-Bremen Klinikum Links der Weser
-
Contact:
- Dr Thorsten Schmidt, MD
-
-
Bavaria
-
Passau, Bavaria, Germany, 94032
- Recruiting
- Herzchirurgische Abteilung Klinikum Passau
-
Contact:
- Dr. Markus Czesla, MD
-
-
Bayern
-
Würzburg, Bayern, Germany, 97080
- Active, not recruiting
- Universitätsklinikum Würzburg
-
-
Saxony
-
Dresden, Saxony, Germany, 01307
- Recruiting
- Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
-
Contact:
- Prof. Dr. Klaus Matschke, MD, PhD
-
-
Thuringia
-
Jena, Thuringia, Germany, 07740
- Recruiting
- Universitätsklinikum Jena
-
Contact:
- Prof. Dr. Torsten Doenst, MD, PhD
-
-
-
-
-
Bologna, Italy, 40138
- Recruiting
- Policlinico S.Orsola-Malpighi
-
Contact:
- Prof Davide Pacini, MD
-
Milan, Italy, 20157
- Withdrawn
- Ospedale Luigi Sacco
-
-
Lombard
-
Milan, Lombard, Italy, 20157
- Recruiting
- Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
-
Contact:
- Prof Carlo Antona, MDA
-
-
Lombardy
-
Milano, Lombardy, Italy, 1350
- Recruiting
- Ospedale San Raffaele - Cardiac
-
Contact:
- Prof. Michele De Bonis, MD
-
-
Piemonte
-
Torino, Piemonte, Italy, 10128
- Recruiting
- Ospedale Umberto I
-
Contact:
- Dr Paolo Centofanti, MD
-
-
-
-
Noord-Brabant
-
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
- Recruiting
- Catharina Ziekenhuis
-
Contact:
- Dr Andrew Tjon, MD
-
-
-
-
Pontevedra
-
Vigo, Pontevedra, Spain, 36312
- Recruiting
- Hospital Alvaro Cunqueiro
-
Contact:
- Dr Juan José Legarra, MD
-
-
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke University Hospital
-
Contact:
- Dr Donald Glower, MD
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- Completed
- University of Wisconsin Hospital and Clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
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.
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.
|
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.
|
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.
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.
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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.
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. |
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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. |
Pre-Operative Baseline, within 60 days post-implant, and 1, 3 and 5 years post-implant
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Vinny Podichetty, Abbott
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABT-CIP-10368
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mitral Regurgitation
-
Abbott Medical DevicesCompletedFunctional Mitral Regurgitation | Degenerrative Mitral RegurgitationRussian Federation
-
Ancora Heart, Inc.CompletedMitral Regurgitation | Mitral Valve Regurgitation | Functional Mitral RegurgitationAustria, Lithuania, Germany
-
Heinrich-Heine University, DuesseldorfCompletedMitral Regurgitation | Functional Mitral Regurgitation | Degenerative Mitral Valve RegurgitationGermany
-
Mitre Medical Corp.BSWRI Cardiac Imaging Core Lab (CICL)Not yet recruitingIschemic Mitral Regurgitation | Functional Mitral RegurgitationUnited States
-
Abbott Medical DevicesCompletedMitral Valve Regurgitation | Mitral Valve Incompetence | Mitral Insufficiency | Functional Mitral Regurgitation | Mitral Stenosis With InsufficiencyJapan
-
Hospital Clinic of BarcelonaAbbottUnknownMITRAL REGURGITATIONSpain
-
Edwards LifesciencesRecruitingMitral Regurgitation | Mitral Insufficiency | Functional Mitral Regurgitation | Degenerative Mitral Valve DiseaseUnited States, Canada, Switzerland, Germany
-
Boston Scientific CorporationActive, not recruitingCardiovascular Diseases | Mitral Regurgitation Functional | Mitral Valve DiseaseUnited States, Australia
-
Abbott Medical DevicesActive, not recruitingHeart Failure | Mitral Regurgitation | Mitral Valve Regurgitation | Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure SubjectsUnited States, Canada
-
Mardil MedicalRecruitingFunctional Mitral RegurgitationCanada, Hungary, France, Germany, Netherlands, Panama, Poland
Clinical Trials on Abbott SJM Rigid Saddle Ring
-
Abbott Medical DevicesCompleted
-
Meshalkin Research Institute of Pathology of CirculationCompletedTricuspid RegurgitationRussian Federation
-
University Hospital, GhentLivaNovaCompleted
-
Meshalkin Research Institute of Pathology of CirculationUnknownMitral Valve InsufficiencyRussian Federation