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Completed

NCT Number: NCT01585779

Contour 3D®/TriAd® 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.

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Key information

Conditions

Tricuspid Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Florida Heart & Vascular Care at Aventura, Aventura, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contour 3D® implant for tricuspid valve repair

Device

Tricuspid annuloplasty ring

Tri-Ad® implant for tricuspid valve repair

Device

Tricuspid annuloplasty ring

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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 outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Registry information

Acronym: Contour3D

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 26, 2012
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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