Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial (Contour3D)

Covidien

Status: Completed

Conditions: Tricuspid Valve Insufficiency; Tricuspid Valve Regurgitation

Treatments: Device: Contour 3D® implant for tricuspid valve repair; Device: Tri-Ad® implant for tricuspid valve repair

Study type: Observational

Funder types: Industry

Identifiers

NCT01585779

10030481DOC

Details and patient eligibility

About

The purpose of this study is to gather clinical information on the hemodynamic performance of the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment.

Full description

The primary goal of the TV repair procedure is to relieve patients from TV insufficiency or reduce TV stenosis. This study will evaluate the hemodynamic efficacy of the Contour 3D® and Tri-Ad® ring and characterize the effect of the TV repair through assessment of right atrial size and right ventricular function. Additionally, this study will characterize the patient population for whom a Contour 3D® or Tri-Ad® ring is chosen to repair TV insufficiency. Health status and adverse events (AE) will be assessed.

Enrollment: 64 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject or legal guardian willing and able to sign and date the Informed Consent Form (and Authorization to Use and Disclose Health Information Form, if applicable)
• Subject indicated for a concomitant surgical repair of the TV
• Subject is willing to return for required follow-up visits to the hospital where the implantation originally occurred

Exclusion criteria

• Subject with a degenerative TV condition
• Subject with primary TV regurgitation
• Subject with a previous TV repair or replacement
• Subject indicated for a stand-alone TV repair
• Subject currently participating in an investigational drug or another device study
• Subject with life expectancy of less than one year
• Subject is pregnant or desires to be pregnant within 12 months following implantation
• Subject is under 18 or over 85 years of age
• Subject with active endocarditis
• Subject with valvular retraction with severely reduced mobility
• Subject with a heavily calcified TV

Trial design

64 participants in 2 patient groups

Contour 3D® Implant

Description:

The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure

Treatment:

Device: Contour 3D® implant for tricuspid valve repair

Tri-Ad® Implant

Description:

The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure

Treatment:

Device: Tri-Ad® implant for tricuspid valve repair