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

NCT01532921 | Completed Results

• 1 other identifier: EASE TRICUSPID
• Study Type: observational
• Target: 85
• Locations: 3 countries
• Sites: 7

Brief 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.

Conditions

Tricuspid Valve Insufficiency

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• 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

• 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

• 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

• Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant

  Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant

Study Arms (1)

Subjects with Tricuspid Valve Repair

All patients indicated for a Tricuspid Valve (TV) repair procedure concomitantly to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.

Procedure: Tricuspid valve repair; Procedure: Left-sided heart surgery; Device: Contour 3D Tricuspid Annuloplasty Ring

Interventions

Tricuspid valve repair PROCEDURE

Subjects with Tricuspid Valve Repair

Left-sided heart surgery PROCEDURE

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

Subjects with Tricuspid Valve Repair

Contour 3D Tricuspid Annuloplasty Ring DEVICE

Contour 3D Tricuspid Annuloplasty procedure was used during the tricuspid valve repair

Subjects with Tricuspid Valve Repair

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient population includes all patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve. Patients with primary TV are not included, since this is often characterized by pathological leaflets for which the Contour 3D® Tricuspid Annuloplasty Ring would not be beneficial.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (7)

Hôpital de Lyon - Hôpital Louis Pradel

Lyon, 69500, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68100, France

Location

Albertinen Herz- und Gefäßzentrum

Hamburg, 22457, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, 23562, Germany

Location

Deutsches Herzzentrum München

Munich, D-80636, Germany

Location

Soroka Medical Center

Be'er Sheeva, 84101, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Related Publications (1)

• Guenzinger R, Lange RS, Riess FC, Hanke T, Bischoff N, Obadia JF, Sahar G, Bitran D, Roberts H Jr, Li S, Bolling SF. Six-Month Performance of a 3-Dimensional Annuloplasty Ring for Repair of Functional Tricuspid Regurgitation. Thorac Cardiovasc Surg. 2020 Sep;68(6):478-485. doi: 10.1055/s-0038-1673665. Epub 2018 Nov 16.

  PMID: 30452076 DERIVED

Related Links

• Sponsor Website

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ber Kleijnen
• Organization: Medtronic, Bakken Research Center Coronary and Structural Heart Disease Management (CSH), Endepolsdomein 5, 6229 GW Maastricht, The Netherlands

ber.kleijnen@medtronic.com

+3143356 6566

Study Officials

• Rüdiger Lange, Prof. Dr.

  Deutsches Herzzentrum München

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2012
• First Posted: February 15, 2012
• Study Start: January 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 10, 2018
• Results First Posted: August 10, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); DE (3); IL (2)