N/A N=85

EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty

Tricuspid Valve Insufficiency

Bottom Line

View on ClinicalTrials.gov: NCT01532921 ↗

Enrolled (actual)

Serious AEs

59.2%

Results posted

Aug 2018

Primary outcome: Primary: Mean Gradient Across the Tricuspid Valve — 1.3; 2.0; 1.9 mmHg

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Tricuspid valve repair (Procedure); Left-sided heart surgery (Procedure); Contour 3D Tricuspid Annuloplasty Ring (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Primary completion: Jan 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Gradient Across the Tricuspid Valve	1.3; 2.0; 1.9	—
PRIMARY Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant	7; 7; 8; 10; 27; 31	—
PRIMARY Change in Tricuspid Valve (TV) Leaflet Coaptation Length From Baseline Through 6 Months Post-implant	-0.6; 0.0	—
PRIMARY Change in the Degree of Tricuspid Valve (TV) Leaflet Tethering Height From Baseline Through 6 Months Post-implant	-0.2; -0.5	—
SECONDARY Change in the Right Ventricle (RV) Diastolic Area From Baseline Through 6 Months Post-implant	160.5; 50.0	—
SECONDARY Change in the Tricuspid Annular Diameter Measured at Diastole From Baseline Through 6 Months Post-implant	—	—
SECONDARY Change in the Right Ventricle (RV) Fractional Area From Baseline Through 6 Months Post-implant	1.7; -1.0	—
SECONDARY Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant	0; 3; 2; 15; 6; 28	—

Summary

Few clinical evidence for the Contour 3D Tricuspid Annuloplasty Ring exists; therefore, in order to position this product on the market, a post-market release study was completed. The purpose of this study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring following Tricuspid Valve (TV) repair in a post-market environment.

Eligibility Criteria

Inclusion Criteria

Willing to sign and date the Patient Informed Consent (PIC)
Indicated for a concomitant surgical repair of the TV
Willing to return to the hospital, where the implantation originally occurred, for a 6 month follow-up visit

Exclusion Criteria

Patients with a degenerative TV condition
Patients with primary TV regurgitation
Previous TV repair or replacement
Stand-alone TV repair
Already participating in another investigational device or drug study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints
Life expectancy of less than one year
Pregnant or desire to be pregnant within 12 months of the study treatment
Under 18 years or over 85 years of age
Patients with active endocarditis
Patients with valvular retraction with severely reduced mobility
Patients with a heavily calcified TV

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01532921). 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.