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

Tricuspid Valve Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532921
• Other study ID #: EASE TRICUSPID
• Status: Completed
• Start date: January 2011
• Est. completion date: January 2016

Study information

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

Clinical Trial 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.

Description:

The EASE TRICUSPID Clinical Trial was a prospective, non-randomized, non-interventional, post-market release study. 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. Therefore, the primary objective of the EASE Tricuspid Study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring (Contour 3D ring) in subjects with tricuspid regurgitation who had a clinical indication for TV repair in a post-market use. Secondary objectives included the evaluation of the effect of TV repair with the Contour 3D ring on the right ventricular function, as well as the assessment of the effect of TV repair with the Contour 3D ring on the functional status in subjects undergoing TV repair in a post-market environment. Subjects eligible for TV repair and compliant with the enrollment criteria were considered by the Investigator for inclusion in the study. To minimize bias, enrolled subjects were followed by their own physician in accordance with the center's established practice for routine follow up. Follow-up sessions were planned at the physician's discretion. To meet the intended goals, appropriate clinical data were collected at baseline (pre-surgery), during the surgical procedure, at discharge and during the follow-up period at 6 months. Experienced echo-cardiologists evaluated the echos. At the time of enrollment it was not certain if the subject would receive a Contour 3D ring, since the surgeon might have decided during surgery that another treatment was more beneficial to the subject. In this case, the subject was terminated from the study.

Recruitment information / eligibility

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

Eligibility

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

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency

Intervention

Procedure:
• Tricuspid valve repair

• Left-sided heart surgery
Tricuspid valve repair was with the study device was only warranted if concomitant left-sided heart surgery was planned

Device:
• Contour 3D Tricuspid Annuloplasty Ring
Contour 3D Tricuspid Annuloplasty procedure was used during the tricuspid valve repair

Locations

Country	Name	City	State
France	Hôpital de Lyon - Hôpital Louis Pradel	Lyon
France	Centre Hospitalier de Mulhouse	Mulhouse
Germany	Albertinen Herz- und Gefäßzentrum	Hamburg
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck
Germany	Deutsches Herzzentrum München	Munich
Israel	Soroka Medical Center	Be'er Sheeva
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

France,  Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Gradient Across the Tricuspid Valve	The mean gradient across the Tricuspid Valve (TV) measured via echocardiography at discharge (up to 5 days post-implant) through 6 months post-implant	At Baseline, Discharge (up to 5 days post-implant) and 6 months post-implant
Primary	Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant	Change in the degree of tricuspid regurgitation measured via echocardiography from Baseline through 6 months post-implant. The severity of tricuspid regurgitation is graded by using several qualitative and quantitative methods. The degree of regurgitation is classified as "none", "Mild", "Moderate" or "Severe".	Baseline to Discharge (up to 5 days post-implant) and through 6 months post-implant
Primary	Change in Tricuspid Valve (TV) Leaflet Coaptation Length From Baseline Through 6 Months Post-implant	Change in the degree of TV leaflet coaptation length measured via echocardiography from Baseline through 6 months post-implant	Baseline to Discharge (up to 5 days post-implant) and to 6 months post-implant
Primary	Change in the Degree of Tricuspid Valve (TV) Leaflet Tethering Height From Baseline Through 6 Months Post-implant	Change in the degree of TV leaflet tethering height measured via echocardiography from Baseline through 6 months post-implant	Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
Secondary	Change in the Right Ventricle (RV) Diastolic Area From Baseline Through 6 Months Post-implant		Basline to Discharge (up to 5 days post-implant) and 6 months post-implant
Secondary	Change in the Tricuspid Annular Diameter Measured at Diastole From Baseline Through 6 Months Post-implant		Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
Secondary	Change in the Right Ventricle (RV) Fractional Area From Baseline Through 6 Months Post-implant		Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
Secondary	Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant	The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. NYHA I implies no limitations. NYHA II implies slight limitation of physical activity. NYHA III implies marked limitation of physical activity and finally, NYHA IV implies patients are Unable to carry on any physical activity without discomfort.	Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant

External Links

•   Sponsor Website