NCT01585779|CompletedResults
Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial
Contour3D
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Contour3D
Sponsor study identifier
observational
64
1 country
3
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 18, 2012
Actual (reported)April 26, 2012
Actual (reported)May 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 2016
Actual (reported)June 2016
Actual (reported)May 10, 2017
Actual (reported)Change in the Degree of Tricuspid Regurgitation
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.
Preimplant through Discharge
Change in the Degree of Tricuspid Regurgitation
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.
Preimplant through 6 Months
Change in the Degree of Tricuspid Regurgitation
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.
Preimplant through 12 Months
The Mean Gradient Across the Tricuspid Valve
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
Discharge
Change in the Right Ventricle (RV) Diastolic Area
Preimplant through Discharge
Change in the Right Ventricle (RV) Diastolic Area
Preimplant through 6 Months
Change in the Right Ventricle (RV) Diastolic Area
Preimplant through 12 Months
Change in the Tricuspid Annular (Basal) Diameter
Preimplant through Discharge
Change in the Tricuspid Annular (Basal) Diameter
Preimplant through 6 Months
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
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
Tricuspid annuloplasty ring
Tricuspid annuloplasty ring
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
Florida Heart & Vascular Care at Aventura
Aventura, Florida, 33308, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mission Hospital Research Institute
Asheville, North Carolina, 28801, United States
Eric Vang
Medtronic
64 participants (actual enrollment reported by the registry).
First Submitted
April 18, 2012
First Posted
April 26, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Measurement of Tricuspid Regurgitation Volume for Assessment of Tricuspid Regurgitation Using 3D Transesophageal Echocardiography
The Mean Gradient Across the Tricuspid Valve
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 months
The Mean Gradient Across the Tricuspid Valve
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
12 months
Change in the Degree of TV Leaflet Coaptation Length
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.
Preimplant through Discharge
Change in the Degree of TV Leaflet Coaptation Length
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.
Preimplant through 6 Months
Change in the Degree of TV Leaflet Coaptation Length
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.
Preimplant through 12 Months
Change in the Degree of TV Leaflet Tethering Height
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.
Preimplant through Discharge
Change in the Degree of TV Leaflet Tethering Height
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.
Preimplant through 6 Months
Change in the Degree of TV Leaflet Tethering Height
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
Preimplant through 12 Months
Contact the study team to confirm eligibility.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
May 10, 2017
Results First Posted
May 10, 2017
Record last verified: 2017-05
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Source: ClinicalTrials.gov.
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