Phase
Condition
Mitral Valve Regurgitation
Cardiovascular Disease
Heart Disease
Treatment
Abbott SJM Séguin Ring
Abbott SJM Tailor Band
Abbott SJM Rigid Saddle Ring
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is expected to undergo cardiac surgery in ≤90 days including at least one ofthe following:
implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cutzone 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 forprimary 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 requiredstudy visits and procedures.
Exclusion
Exclusion Criteria:
Subject is below the age of legal consent in the applicable jurisdiction orotherwise lacks legal authority to provide informed consent.
Subject is unable to read or write or has a mental illness or disability thatimpairs their ability to provide written informed consent.
Subject is expected to have active endocarditis at the time of their Abbottannuloplasty device implant(s).
Subject cannot be unambiguously assigned to a treatment group due to missing data onrepair indication(s) or the model and configuration (cut zone removed or not) oftheir Abbott annuloplasty implant(s).
Subject is participating in another clinical investigation including any treatmentoutside the investigative site's usual standard of care.
Subject has anomalous anatomy or medical, surgical, psychiatric or social history orconditions that, in the investigator's opinion, would limit the subject's ability toparticipate in the clinical investigation or to comply with follow-up requirements
Study Design
Study Description
Connect with a study center
Tartu University Hospital
Tartu, 50406
EstoniaActive - Recruiting
Hopital Cardiovasculaire et Pneumologique Louis Pradel
Lyon, Auvergne-Rhône-Alpes 69500
FranceActive - Recruiting
CHU de Besançon - Jean Minjoz
Besançon, Bourgogne-Franche-Comté 25000
FranceActive - Recruiting
Herzchirurgische Abteilung Klinikum Passau
Passau, Bavaria 94032
GermanyActive - Recruiting
Universitätsklinikum Würzburg
Würzburg, Bayern 97080
GermanySite Not Available
Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
Dresden, Saxony 01307
GermanyActive - Recruiting
Universitätsklinikum Jena
Jena, Thuringia 07740
GermanyActive - Recruiting
Herzzentrum-Bremen Klinikum Links der Weser
Bremen, 28211
GermanyActive - Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombard 20157
ItalyActive - Recruiting
Ospedale San Raffaele - Cardiac
Milano, Lombardy 1350
ItalyActive - Recruiting
Ospedale Umberto I
Torino, Piemonte 10128
ItalyActive - Recruiting
Policlinico S.Orsola-Malpighi
Bologna, 40138
ItalyActive - Recruiting
Ospedale Luigi Sacco
Milan, 20157
ItalySite Not Available
Catharina Ziekenhuis
Eindhoven, Noord-Brabant 5623 EJ
NetherlandsActive - Recruiting
Hospital Alvaro Cunqueiro
Vigo, Pontevedra 36312
SpainActive - Recruiting
Duke University Hospital
Durham, North Carolina 27710
United StatesSite Not Available
University of Wisconsin Hospital and Clinics
Madison, Wisconsin 53792
United StatesSite Not Available
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