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
  Purpose

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.


Condition Intervention Phase
Tricuspid Valve Regurgitation
Tricuspid Valve Insufficiency
Device: Contour 3D® or Tri-Ad® implant for tricuspid valve repair
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contour 3D®/Tri-Ad® Tricuspid Annuloplasty Ring Post-Market Clinical Trial

Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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
Device: Contour 3D® or Tri-Ad® implant for tricuspid valve repair

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585779

Contacts
Contact: Shari Benoit 763-514-9749 shari.g.benoit@medtronic.com

Locations
United States, Florida
Aegis Cardiovascular Research Foundation Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: M. Arif Mahmood, M.D., M.P.H.    954-655-0960      
Principal Investigator: Harold Roberts, M.D.         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cathie Bloem, M.P.H., R.N.    734-615-6170      
Principal Investigator: Steven Bolling, M.D.         
United States, North Carolina
Mission Hospital Research Institute Not yet recruiting
Asheville, North Carolina, United States, 28801
Principal Investigator: Alan M Johnson, MD         
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Study Director: Susan H Knox, MBA, BS Medtronic
  More Information

Additional Information:
No publications provided

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01585779     History of Changes
Other Study ID Numbers: 10030481DOC
Study First Received: April 18, 2012
Last Updated: July 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014