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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-06-30

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.

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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.

Conditions

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Tricuspid Valve Regurgitation Tricuspid Valve Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Contour 3D® Implant

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

Contour 3D® implant for tricuspid valve repair

Intervention Type DEVICE

Tricuspid annuloplasty ring

Tri-Ad® Implant

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

Tri-Ad® implant for tricuspid valve repair

Intervention Type DEVICE

Tricuspid annuloplasty ring

Interventions

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Contour 3D® implant for tricuspid valve repair

Tricuspid annuloplasty ring

Intervention Type DEVICE

Tri-Ad® implant for tricuspid valve repair

Tricuspid annuloplasty ring

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No