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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency

Intervention / Treatment
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* Device: Contour 3D® implant for tricuspid valve repair
* Device: Tri-Ad® implant for tricuspid valve repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Contour 3D® Implant<br>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 | Device: Contour 3D® implant for tricuspid valve repair<br>* Tricuspid annuloplasty ring<br>|
| Tri-Ad® Implant<br>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 | Device: Tri-Ad® implant for tricuspid valve repair<br>* Tricuspid annuloplasty ring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Degree of Tricuspid Regurgitation | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant. | Preimplant through Discharge | 
| Change in the Degree of Tricuspid Regurgitation | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant. | Preimplant through 6 Months | 
| Change in the Degree of Tricuspid Regurgitation | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant. | Preimplant through 12 Months | 
| The Mean Gradient Across the Tricuspid Valve | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant | Discharge | 
| The Mean Gradient Across the Tricuspid Valve | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant | 6 months | 
| The Mean Gradient Across the Tricuspid Valve | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant | 12 months | 
| Change in the Degree of TV Leaflet Coaptation Length | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant. | Preimplant through Discharge | 
| Change in the Degree of TV Leaflet Coaptation Length | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant. | Preimplant through 6 Months | 
| Change in the Degree of TV Leaflet Coaptation Length | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant. | Preimplant through 12 Months | 
| Change in the Degree of TV Leaflet Tethering Height | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant. | Preimplant through Discharge | 
| Change in the Degree of TV Leaflet Tethering Height | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant. | Preimplant through 6 Months | 
| Change in the Degree of TV Leaflet Tethering Height | The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant | Preimplant through 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Right Ventricle (RV) Diastolic Area | The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant. | Preimplant through Discharge | 
| Change in the Right Ventricle (RV) Diastolic Area | The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant. | Preimplant through 6 Months | 
| Change in the Right Ventricle (RV) Diastolic Area | The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant | Preimplant through 12 Months | 
| Change in the Tricuspid Annular (Basal) Diameter | The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant | Preimplant through Discharge | 
| Change in the Tricuspid Annular (Basal) Diameter | The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant | Preimplant through 6 Months | 
| Change in the Tricuspid Annular (Basal) Diameter | The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant | Preimplant through 12 Months | 
| Change in the RV Fractional Area | The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant. | Preimplant through Discharge | 
| Change in the RV Fractional Area | The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant. | Preimplant through 6 Months | 
| Change in the RV Fractional Area | The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant. | Preimplant through 12 Months | 
| Demographic Data | Characterize the patient population for which an annuloplasty ring is chosen to repair TV insufficiency and assess the effect of TV repair with the study ring on the tricuspid valve functional status | Baseline | 
| Change in New York Heart Association (NYHA) Classification | Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant. | Preimplant through Discharge | 
| Change in New York Heart Association (NYHA) Classification | Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant. | Preimplant through 6 months | 
| Change in New York Heart Association (NYHA) Classification . | Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant. | Preimplant through 12 months |