EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty
Condition: Tricuspid Valve Insufficiency
MeSH terms: Tricuspid Valve Insufficiency
Study type: Observational

Summary: 
      Few clinical evidence for the Contour 3D Tricuspid Annuloplasty Ring exists; therefore, in
      order to position this product on the market, a post-market release study was completed. The
      purpose of this study was to evaluate the hemodynamic performance of the Contour 3D®
      Tricuspid Annuloplasty Ring following Tricuspid Valve (TV) repair in a post-market
      environment.
    

Detailed description: 
      The EASE TRICUSPID Clinical Trial was a prospective, non-randomized, non-interventional,
      post-market release study. The purpose of this study was to evaluate the hemodynamic
      performance of the Contour 3D® Tricuspid Annuloplasty Ring following Tricuspid Valve (TV)
      repair in a post-market environment. Therefore, the primary objective of the EASE Tricuspid
      Study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty
      Ring (Contour 3D ring) in subjects with tricuspid regurgitation who had a clinical indication
      for TV repair in a post-market use. Secondary objectives included the evaluation of the
      effect of TV repair with the Contour 3D ring on the right ventricular function, as well as
      the assessment of the effect of TV repair with the Contour 3D ring on the functional status
      in subjects undergoing TV repair in a post-market environment. Subjects eligible for TV
      repair and compliant with the enrollment criteria were considered by the Investigator for
      inclusion in the study. To minimize bias, enrolled subjects were followed by their own
      physician in accordance with the center's established practice for routine follow up.
      Follow-up sessions were planned at the physician's discretion. To meet the intended goals,
      appropriate clinical data were collected at baseline (pre-surgery), during the surgical
      procedure, at discharge and during the follow-up period at 6 months. Experienced
      echo-cardiologists evaluated the echos. At the time of enrollment it was not certain if the
      subject would receive a Contour 3D ring, since the surgeon might have decided during surgery
      that another treatment was more beneficial to the subject. In this case, the subject was
      terminated from the study.
    

Intervention name(s): Tricuspid valve repair; Left-sided heart surgery; Contour 3D Tricuspid Annuloplasty Ring
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): Tricuspid valve repair was with the study device was only warranted if concomitant left-sided heart surgery was planned; Contour 3D Tricuspid Annuloplasty procedure was used during the tricuspid valve repair
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patient population includes all patients indicated for a TV repair procedure
        concomitantly to left-sided heart surgery, and for whom the surgeon considers the
        implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct
        the diseased valve. Patients with primary TV are not included, since this is often
        characterized by pathological leaflets for which the Contour 3D® Tricuspid Annuloplasty
        Ring would not be beneficial.