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

Tricuspid Valve Insufficiency Clinical Trial

— Contour3D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585779
• Other study ID #: 10030481DOC
• Status: Completed
• Phase: N/A
• First received: April 18, 2012
• Last updated: May 4, 2017
• Start date: May 2012
• Est. completion date: June 2016

Study information

• Verified date: May 2017
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency
• Tricuspid Valve Regurgitation

Intervention

Device:
• Contour 3D® implant for tricuspid valve repair
Tricuspid annuloplasty ring
• Tri-Ad® implant for tricuspid valve repair
Tricuspid annuloplasty ring

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Mission Hospital Research Institute	Asheville	North Carolina
United States	Florida Heart & Vascular Care at Aventura	Aventura	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Change in the Right Ventricle (RV) Diastolic Area	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.	Preimplant through Discharge
Secondary	Change in the Right Ventricle (RV) Diastolic Area	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.	Preimplant through 6 Months
Secondary	Change in the Right Ventricle (RV) Diastolic Area	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	Preimplant through 12 Months
Secondary	Change in the Tricuspid Annular (Basal) Diameter	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	Preimplant through Discharge
Secondary	Change in the Tricuspid Annular (Basal) Diameter	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	Preimplant through 6 Months
Secondary	Change in the Tricuspid Annular (Basal) Diameter	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	Preimplant through 12 Months
Secondary	Change in the RV Fractional Area	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.	Preimplant through Discharge
Secondary	Change in the RV Fractional Area	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.	Preimplant through 6 Months
Secondary	Change in the RV Fractional Area	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.	Preimplant through 12 Months
Secondary	Demographic Data	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	Baseline
Secondary	Change in New York Heart Association (NYHA) Classification	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.	Preimplant through Discharge
Secondary	Change in New York Heart Association (NYHA) Classification	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.	Preimplant through 6 months
Secondary	Change in New York Heart Association (NYHA) Classification .	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.	Preimplant through 12 months

External Links

•   Sponsor website