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Tricuspid Valve InsufficiencyNCT01532921

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

An observational study of Tricuspid Valve Insufficiency, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Tricuspid Valve Insufficiency
What is being tested?
Tricuspid valve repair, Left-sided heart surgery and Contour 3D Tricuspid Annuloplasty Ring
How many people
85 participants
Where
7 sitesin 3 countries
Study dates
Jan 2011to Jan 2016
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

Germany3 sites

  • Albertinen Herz- und Gefäßzentrum

    Hamburg, 22457

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23562

  • Deutsches Herzzentrum München

    Munich, D-80636

Other trials in Germany

France2 sites

  • Hôpital de Lyon - Hôpital Louis Pradel

    Lyon, 69500

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68100

Other trials in France

Israel2 sites

  • Soroka Medical Center

    Be'er Sheeva, 84101

  • Shaare Zedek Medical Center

    Jerusalem

Other trials in Israel

About this study

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.

Read the 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.

Being tested
Tricuspid valve repair, Left-sided heart surgery, Contour 3D Tricuspid Annuloplasty Ring
Medical subject headings
Tricuspid Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tricuspid valve repairProcedure or surgery

  • Left-sided heart surgeryProcedure or surgery

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

  • Contour 3D Tricuspid Annuloplasty RingDevice

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

Study groups in NCT01532921
Study groupRoleWhat they receive
Subjects with Tricuspid Valve RepairAll 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.
Receives: Procedure: Tricuspid valve repair; Procedure: Left-sided heart surgery; Device: Contour 3D Tricuspid Annuloplasty Ring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At Baseline, Discharge (up to 5 days post-implant) and 6 months post-implant

  2. 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".

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

  3. 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

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

  4. 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

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

Secondary outcomes (4)

  1. Change in the Right Ventricle (RV) Diastolic Area From Baseline Through 6 Months Post-implant

    Measured: Basline to Discharge (up to 5 days post-implant) and 6 months post-implant

  2. Change in the Tricuspid Annular Diameter Measured at Diastole From Baseline Through 6 Months Post-implant

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

  3. Change in the Right Ventricle (RV) Fractional Area From Baseline Through 6 Months Post-implant

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2012 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01532921
Sponsor's protocol ID
EASE TRICUSPID
Status last verified
Nov 2017
First submitted
10 Feb 2012
Last updated
10 Aug 2018
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30452076

Questions about this trial

What is this clinical trial studying?

An observational study of Tricuspid Valve Insufficiency, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany, France, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Gradient Across the Tricuspid Valve (time frame: At Baseline, Discharge (up to 5 days post-implant) and 6 months post-implant). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01532921, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.

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