N/A N=64

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

Tricuspid Valve Regurgitation · Tricuspid Valve Insufficiency

Bottom Line

View on ClinicalTrials.gov: NCT01585779 ↗

Enrolled (actual)

Serious AEs

40.6%

Results posted

May 2017

Primary outcome: Primary: Change in the Degree of Tricuspid Regurgitation — 27; 18; 6; 6 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Contour 3D® implant for tricuspid valve repair (Device); Tri-Ad® implant for tricuspid valve repair (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medtronic Cardiovascular
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Degree of Tricuspid Regurgitation	17; 12; 5; 7; 3; 1	—
PRIMARY Change in the Degree of Tricuspid Regurgitation	17; 12; 5; 7; 3; 1	—
PRIMARY Change in the Degree of Tricuspid Regurgitation	17; 12; 5; 7; 3; 1	—
PRIMARY The Mean Gradient Across the Tricuspid Valve	2.0; 2.0	—
PRIMARY The Mean Gradient Across the Tricuspid Valve	2.0; 2.0	—
PRIMARY The Mean Gradient Across the Tricuspid Valve	2.0; 2.0	—
PRIMARY Change in the Degree of TV Leaflet Coaptation Length	0.0; 0.0	—
PRIMARY Change in the Degree of TV Leaflet Coaptation Length	0.0; 0.0	—
PRIMARY Change in the Degree of TV Leaflet Coaptation Length	0.0; 0.0	—
PRIMARY Change in the Degree of TV Leaflet Tethering Height	1.0; 1.0	—
PRIMARY Change in the Degree of TV Leaflet Tethering Height	1.0; 1.0	—
PRIMARY Change in the Degree of TV Leaflet Tethering Height	1.0; 1.0	—
SECONDARY Change in the Right Ventricle (RV) Diastolic Area	395.0; 211.0	—
SECONDARY Change in the Right Ventricle (RV) Diastolic Area	395.0; 211.0	—
SECONDARY Change in the Right Ventricle (RV) Diastolic Area	395.0; 211.0	—
SECONDARY Change in the Tricuspid Annular (Basal) Diameter	4.0; 1.0	—
SECONDARY Change in the Tricuspid Annular (Basal) Diameter	4.0; 1.0	—
SECONDARY Change in the Tricuspid Annular (Basal) Diameter	4.0; 1.0	—
SECONDARY Change in the RV Fractional Area	-0.4; -3.6	—
SECONDARY Change in the RV Fractional Area	-0.4; -3.6	—
SECONDARY Change in the RV Fractional Area	-0.4; -3.6	—
SECONDARY Demographic Data	5; 1; 2; 3; 6; 5	—
SECONDARY Change in New York Heart Association (NYHA) Classification	20; 19; 8; 1; 2; 1	—
SECONDARY Change in New York Heart Association (NYHA) Classification	20; 19; 8; 1; 2; 1	—
SECONDARY Change in New York Heart Association (NYHA) Classification .	19; 17; 7; 3; 0; 1	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01585779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.