Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study

Official title

Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study

Overview

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.

Interventions

• Device Abbott SJM Rigid Saddle Ring
  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.
• Device Abbott SJM Séguin Ring
  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.
• Device Abbott SJM Tailor Ring
  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.
• Device Abbott SJM Tailor 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.

Primary outcome measures

• 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 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 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]

Secondary outcome measures (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 [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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 5 centers

• Herzchirurgische Abteilung Klinikum Passau — Passau
• Universitätsklinikum Würzburg — Würzburg
• Herzzentrum-Bremen Klinikum Links der Weser — Bremen
• Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden — Dresden
• Universitätsklinikum Jena — Jena

Italy · 5 centers

• Policlinico S.Orsola-Malpighi — Bologna
• Ospedale San Raffaele - Cardiac — Milan
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan
• Ospedale Luigi Sacco — Milan
• Ospedale Umberto I — Turin

United States · 2 centers

• Duke University Hospital — Durham
• University of Wisconsin Hospital and Clinics — Madison

France · 2 centers

• Hopital Cardiovasculaire et Pneumologique Louis Pradel — Lyon
• CHU de Besançon - Jean Minjoz — Besançon

Estonia · 1 center

• Tartu University Hospital — Tartu

Netherlands · 1 center

• Catharina Ziekenhuis — Eindhoven

Spain · 1 center

• Hospital Alvaro Cunqueiro — Vigo

Identifiers

NCT: NCT04761120 · ABT-CIP-10368

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗