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

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

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.

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.

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