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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Medtronic Cardiovascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01585779
First received: April 18, 2012
Last updated: July 1, 2013
Last verified: July 2013

April 18, 2012
July 1, 2013
May 2012
March 2014   (final data collection date for primary outcome measure)
Evaluate the hemodynamic performance of the tricuspid valve following implantation of a tricuspid annuloplasty ring in a post-market environment [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant

Mean gradient across the tricuspid valve - The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant

TV leaflet coaptation length - Change in the degree of TV leaflet coaptation length from pre-implant through 12 months post-implant

TV leaflet tethering height - Change in the degree of TV leaflet tethering height pre-implant through 12 months post-implant

Evaluate the hemodynamic performance of the Contour 3D® ring in the tricuspid position following TV repair [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant

Mean gradient across the tricuspid valve - The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months postimplant

TV leaflet coaptation length - Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant

TV leaflet tethering height - Change in the degree of TV leaflet tethering height preimplant through 12 months postimplant

Complete list of historical versions of study NCT01585779 on ClinicalTrials.gov Archive Site
  • 1. Evaluate the effect of TV repair with the study ring on right atrial size and right ventricular function [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

    Change in the following right ventricular dimensions from preimplant through 12 months post-implant

    • Right ventricle (RV) diastolic area
    • Tricuspid annular diameter at diastole
    • RV functional area
    • Right atrial dimensions, major and minor
  • 2. 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 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    • Demographic data
    • Change in New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant
  • Evaluate the effect of TV repair with the Contour 3D® ring on right ventricular function [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

    Change in the following right ventricular dimensions from preimplant through 12 months post-implant

    • Right ventricle (RV) diastolic area measured via echocardiography
    • Tricuspid annular diameter measured at diastole
    • RV functional area
  • 2. Assess the effect of TV repair with the Contour 3D® ring on functional status in the patient population undergoing TV repair in a post-market environment [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    • Characterize the patient population for which a Contour 3D® ring is chosen to repair TV insufficiency as measured by demographic data
    • Change in New York Heart Association (NYHA) classification from preimplant through 12 months postimplant
Not Provided
Not Provided
 
Contour 3D®/Tri-Ad® Tricuspid Annuloplasty Ring Post-Market Clinical Trial
Contour 3D®/Tri-Ad® Tricuspid Annuloplasty Ring Post-Market Clinical Trial

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.

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 which a Contour 3D® or Tri-Ad® ring is chosen to repair TV insufficiency. Health status and adverse events (AE) will be assessed.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® or 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 Contour 3D® or Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure

  • Tricuspid Valve Regurgitation
  • Tricuspid Valve Insufficiency
Device: Contour 3D® or Tri-Ad® implant for tricuspid valve repair
  • Contour 3D® Implant
    The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for which 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
    Intervention: Device: Contour 3D® or Tri-Ad® implant for tricuspid valve repair
  • Tri-Ad® Implant
    The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for which 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
    Intervention: Device: Contour 3D® or Tri-Ad® implant for tricuspid valve repair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2015
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Shari Benoit 763-514-9749 shari.g.benoit@medtronic.com
United States
 
NCT01585779
10030481DOC
No
Medtronic Cardiovascular
Medtronic Cardiovascular
Not Provided
Study Director: Susan H Knox, MBA, BS Medtronic
Medtronic Cardiovascular
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP