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

Completed

Conditions: Tricuspid Valve Regurgitation
Tricuspid Valve Insufficiency

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

Registration Number: NCT01585779

Lead Sponsor: Medtronic Cardiovascular

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 64

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tri-Ad® Implant	Tri-Ad® implant for tricuspid valve repair	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
Contour 3D® Implant	Contour 3D® implant for tricuspid valve repair	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

Primary Outcome Measures

Name	Time	Method
Change in the Degree of Tricuspid Regurgitation	Preimplant through 12 Months	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.
The Mean Gradient Across the Tricuspid Valve	12 months	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
Change in the Degree of TV Leaflet Coaptation Length	Preimplant through 12 Months	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.
Change in the Degree of TV Leaflet Tethering Height	Preimplant through 12 Months	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

Secondary Outcome Measures

Name	Time	Method
Demographic Data	Baseline	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
Change in the RV Fractional Area	Preimplant through 12 Months	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.
Change in the Tricuspid Annular (Basal) Diameter	Preimplant through 12 Months	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
Change in New York Heart Association (NYHA) Classification .	Preimplant through 12 months	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.
Change in the Right Ventricle (RV) Diastolic Area	Preimplant through 12 Months	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
Change in New York Heart Association (NYHA) Classification	Preimplant through 6 months	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.

Trial Locations

Locations (3): Florida Heart & Vascular Care at Aventura
🇺🇸
Aventura, Florida, United States
Mission Hospital Research Institute
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Asheville, North Carolina, United States
University of Michigan
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Ann Arbor, Michigan, United States