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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
ClinicalTrials.gov Identifier:
NCT01532921
First received: February 10, 2012
Last updated: April 28, 2017
Last verified: April 2017
  Purpose
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 repair in a post-market environment.

Condition
Tricuspid Valve Insufficiency

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty

Further study details as provided by Medtronic Cardiovascular ( Medtronic Bakken Research Center ):

Primary Outcome Measures:
  • Mean Gradient across the TV [ Time Frame: discharge through 6 months post-implant ]
    The mean gradient across the TV measured via echocardiography at discharge through 6 months post-implant

  • Degree of TV regurgitation [ Time Frame: pre-implant through 6 months post-implant ]
    Change in the degree of tricuspid regurgitation measured via echocardiography from pre-implant through 6 months post-implant

  • TV leaflet coaptation length [ Time Frame: pre-implant through 6 months post-implant ]
    Change in the degree of TV leaflet coaptation length measured via echocardiography from pre-implant through 6 months post-implant

  • TV leaflet tethering height [ Time Frame: pre-implant through 6 months post-implant ]
    Change in the degree of TV leaflet tethering height measured via echocardiography from pre-implant through 6 months post-implant


Secondary Outcome Measures:
  • Change in the Right ventricle (RV) diastolic area from pre-implant through 6 months post-implant [ Time Frame: pre-implant through 6 months post-implant ]
  • Change in the Tricuspid annular diameter measured at diastole from pre-implant through 6 months post-implant [ Time Frame: pre-implant through 6 months post-implant ]
  • Change in the RV fractional area from pre-implant through 6 months post-implant [ Time Frame: pre-implant through 6 months post-implant ]
  • Characteristics of the subject population for which a Contour 3D ring is chosen to repair TV insufficiency as measured by demographic data [ Time Frame: Baseline ]
  • Change in New York Heart Association (NYHA) classification from pre-implant through 6 months post-implant [ Time Frame: pre-implant through 6 months post-implant ]

Enrollment: 85
Study Start Date: September 2011
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Indicated for a TV repair procedure
All patients indicated for a TV repair procedure concomitantly to left-sided heart surgery, and for which the surgeon considers the implantation of a Contour 3D® Tricuspid Annuloplasty Ring most appropriate to reconstruct the diseased valve.

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 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 echocardiologists 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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 which 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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532921

Locations
France
Hôpital de Lyon - Hôpital Louis Pradel
Lyon, France, 69500
Centre Hospitalier de Mulhouse
Mulhouse, France, 68100
Germany
Albertinen Herz- und Gefäßzentrum
Hamburg, Germany, 22457
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany, 23562
Deutsches Herzzentrum München
Munich, Germany, D-80636
Israel
Soroka Medical Center
Be'er Sheeva, Israel, 84101
Shaare Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Rüdiger Lange, Prof. Dr. Deutsches Herzzentrum München
  More Information

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01532921     History of Changes
Other Study ID Numbers: EASE TRICUSPID
Study First Received: February 10, 2012
Last Updated: April 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 19, 2017