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 7, 2016
Last verified: April 2016

February 10, 2012
April 7, 2016
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in the degree of TV leaflet tethering height measured via echocardiography from pre-implant through 6 months post-implant
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Complete list of historical versions of study NCT01532921 on ClinicalTrials.gov Archive Site
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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 will be completed. The purpose of this study is to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring following Tricuspid Valve repair in a post-market environment.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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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
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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.
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*   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
Both
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
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Medtronic Bakken Research Center
Medtronic Bakken Research Center
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Principal Investigator: Rüdiger Lange, Prof. Dr. med. Deutsches Herzzentrum München
Medtronic Cardiovascular
April 2016

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