Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Cardiovascular
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.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
