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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Abbott Medical Devices
Study ID
NCT04761120
Status
Recruiting
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Conditions

  • Mitral Regurgitation
  • Tricuspid Regurgitation
  • Valvular Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abbott SJM Rigid Saddle Ring — DEVICE
    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 Ring — DEVICE
    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 Ring — DEVICE
    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 Band — DEVICE
    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 Details

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.

Key Dates

Start date
Feb 1, 2021
Status verified
May 2026
Primary completion
Nov 30, 2030
Completion
Mar 31, 2031

Study Design

Enrollment
550 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Duke University HospitalDurhamNorth Carolina27710-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Durham, NC

By research site
Duke University Hospital· Durham, NCUniversity of Wisconsin Hospital and Clinics· Madison, WI

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