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Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial (Contour3D)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01585779
First received: April 18, 2012
Last updated: May 4, 2017
Last verified: May 2017
  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
Tricuspid Valve Regurgitation Tricuspid Valve Insufficiency Device: Contour 3D® implant for tricuspid valve repair Device: Tri-Ad® implant for tricuspid valve repair

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

Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • Change in the Degree of Tricuspid Regurgitation [ Time Frame: Preimplant through Discharge ]

    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.

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


  • Change in the Degree of Tricuspid Regurgitation [ Time Frame: Preimplant through 6 Months ]

    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.

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


  • Change in the Degree of Tricuspid Regurgitation [ Time Frame: Preimplant through 12 Months ]

    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.

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


  • The Mean Gradient Across the Tricuspid Valve [ Time Frame: Discharge ]
    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant

  • The Mean Gradient Across the Tricuspid Valve [ Time Frame: 6 months ]
    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant

  • The Mean Gradient Across the Tricuspid Valve [ Time Frame: 12 months ]
    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant

  • Change in the Degree of TV Leaflet Coaptation Length [ Time Frame: Preimplant through Discharge ]
    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.

  • Change in the Degree of TV Leaflet Coaptation Length [ Time Frame: Preimplant through 6 Months ]
    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.

  • Change in the Degree of TV Leaflet Coaptation Length [ Time Frame: Preimplant through 12 Months ]
    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.

  • Change in the Degree of TV Leaflet Tethering Height [ Time Frame: Preimplant through Discharge ]
    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.

  • Change in the Degree of TV Leaflet Tethering Height [ Time Frame: Preimplant through 6 Months ]
    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.

  • Change in the Degree of TV Leaflet Tethering Height [ Time Frame: Preimplant through 12 Months ]
    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant


Secondary Outcome Measures:
  • Change in the Right Ventricle (RV) Diastolic Area [ Time Frame: Preimplant through Discharge ]
    The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant.

  • Change in the Right Ventricle (RV) Diastolic Area [ Time Frame: Preimplant through 6 Months ]
    The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant.

  • Change in the Right Ventricle (RV) Diastolic Area [ Time Frame: Preimplant through 12 Months ]
    The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant

  • Change in the Tricuspid Annular (Basal) Diameter [ Time Frame: Preimplant through Discharge ]
    The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant

  • Change in the Tricuspid Annular (Basal) Diameter [ Time Frame: Preimplant through 6 Months ]
    The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant

  • Change in the Tricuspid Annular (Basal) Diameter [ Time Frame: Preimplant through 12 Months ]
    The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant

  • Change in the RV Fractional Area [ Time Frame: Preimplant through Discharge ]
    The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.

  • Change in the RV Fractional Area [ Time Frame: Preimplant through 6 Months ]
    The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.

  • Change in the RV Fractional Area [ Time Frame: Preimplant through 12 Months ]
    The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.

  • Demographic Data [ Time Frame: Baseline ]
    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

  • Change in New York Heart Association (NYHA) Classification [ Time Frame: Preimplant through Discharge ]
    Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.

  • Change in New York Heart Association (NYHA) Classification [ Time Frame: Preimplant through 6 months ]
    Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.

  • Change in New York Heart Association (NYHA) Classification . [ Time Frame: Preimplant through 12 months ]
    Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.


Enrollment: 64
Study Start Date: May 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (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 whom 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® implant for tricuspid valve repair
Tricuspid annuloplasty ring
Tri-Ad® Implant
The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom 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: Tri-Ad® implant for tricuspid valve repair
Tricuspid annuloplasty ring

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 whom 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

Locations
United States, Florida
Florida Heart & Vascular Care at Aventura
Aventura, Florida, United States, 33308
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
Mission Hospital Research Institute
Asheville, North Carolina, United States, 28801
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Study Director: Eric Vang Medtronic
  More Information

Additional Information:
Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01585779     History of Changes
Other Study ID Numbers: 10030481DOC
Study First Received: April 18, 2012
Results First Received: March 21, 2017
Last Updated: May 4, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017