- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01532921
EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty
November 16, 2017 updated by: Medtronic Bakken Research Center
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
85
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lyon, France, 69500
- Hôpital de Lyon - Hôpital Louis Pradel
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Mulhouse, France, 68100
- Centre Hospitalier de Mulhouse
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Hamburg, Germany, 22457
- Albertinen Herz- und Gefäßzentrum
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Lübeck, Germany, 23562
- Universitätsklinikum Schleswig-Holstein
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Munich, Germany, D-80636
- Deutsches Herzzentrum München
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Be'er Sheeva, Israel, 84101
- Soroka Medical Center
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Jerusalem, Israel
- Shaare Zedek Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Tricuspid valve repair was with the study device was only warranted if concomitant left-sided heart surgery was planned
Contour 3D Tricuspid Annuloplasty procedure was used during the tricuspid valve repair
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Mean Gradient Across the Tricuspid Valve
Time Frame: At Baseline, Discharge (up to 5 days post-implant) and 6 months post-implant
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The mean gradient across the Tricuspid Valve (TV) measured via echocardiography at discharge (up to 5 days post-implant) through 6 months post-implant
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At Baseline, Discharge (up to 5 days post-implant) and 6 months post-implant
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Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant
Time Frame: Baseline to Discharge (up to 5 days post-implant) and through 6 months post-implant
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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".
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Baseline to Discharge (up to 5 days post-implant) and through 6 months post-implant
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Change in Tricuspid Valve (TV) Leaflet Coaptation Length From Baseline Through 6 Months Post-implant
Time Frame: Baseline to Discharge (up to 5 days post-implant) and to 6 months post-implant
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Change in the degree of TV leaflet coaptation length measured via echocardiography from Baseline through 6 months post-implant
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Baseline to Discharge (up to 5 days post-implant) and to 6 months post-implant
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Change in the Degree of Tricuspid Valve (TV) Leaflet Tethering Height From Baseline Through 6 Months Post-implant
Time Frame: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
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Change in the degree of TV leaflet tethering height measured via echocardiography from Baseline through 6 months post-implant
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Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in the Right Ventricle (RV) Diastolic Area From Baseline Through 6 Months Post-implant
Time Frame: Basline to Discharge (up to 5 days post-implant) and 6 months post-implant
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Basline to Discharge (up to 5 days post-implant) and 6 months post-implant
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Change in the Tricuspid Annular Diameter Measured at Diastole From Baseline Through 6 Months Post-implant
Time Frame: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
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Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
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Change in the Right Ventricle (RV) Fractional Area From Baseline Through 6 Months Post-implant
Time Frame: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
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Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
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Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant
Time Frame: Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
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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.
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Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (ACTUAL)
January 1, 2016
Study Completion (ACTUAL)
January 1, 2016
Study Registration Dates
First Submitted
February 10, 2012
First Submitted That Met QC Criteria
February 10, 2012
First Posted (ESTIMATE)
February 15, 2012
Study Record Updates
Last Update Posted (ACTUAL)
August 10, 2018
Last Update Submitted That Met QC Criteria
November 16, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EASE TRICUSPID
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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