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

Completed

Conditions studied: Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency

In brief

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.

Key facts

Study ID: NCT01585779
Run by: Medtronic Cardiovascular
People needed: 64
Starts: 2012-05-01
Expected to finish: 2016-06-01
Last updated by the study team: 2017-05-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Florida Heart & Vascular Care at Aventura — Aventura, Florida, United States
University of Michigan — Ann Arbor, Michigan, United States
Mission Hospital Research Institute — Asheville, North Carolina, United States

Full record on ClinicalTrials.gov

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