NCT01585779

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tricuspid Valve Regurgitation
• Tricuspid Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	Contour 3D® implant for tricuspid valve repair	Tricuspid annuloplasty ring
DEVICE	Tri-Ad® implant for tricuspid valve repair	Tricuspid annuloplasty ring

Timeline

• Start date: 2012-05-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2012-04-26
• Last updated: 2017-05-10
• Results posted: 2017-05-10

Locations

3 sites across 1 country: United States