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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
February 10, 2012
April 28, 2017
September 2011
December 2015   (Final data collection date for primary outcome measure)
  • 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
Not Provided
Complete list of historical versions of study NCT01532921 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty
EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Tricuspid Valve Insufficiency
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Israel
Netherlands
 
NCT01532921
EASE TRICUSPID
No
Not Provided
Plan to Share IPD: No
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
Medtronic Bakken Research Center
Not Provided
Principal Investigator: Rüdiger Lange, Prof. Dr. Deutsches Herzzentrum München
Medtronic Cardiovascular
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP