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

This study is currently recruiting participants.
Verified March 2013 by Medtronic Bakken Research Center
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01532921
First received: February 10, 2012
Last updated: March 23, 2013
Last verified: March 2013

February 10, 2012
March 23, 2013
September 2011
March 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
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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.

Evaluate the Hemodynamic Performance
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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.
 
Recruiting
85
August 2015
March 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
No
Contact: Anneleen Daniels +31 43 356 6789 anneleen.daniels@medtronic.com
Contact: Ber Kleijnen +31 43 356 6812 ber.kleijnen@medtronic.com
Germany
 
NCT01532921
EASE TRICUSPID
No
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Not Provided
Principal Investigator: Rüdiger Lange, Prof. Dr. med. Deutsches Herzzentrum München
Medtronic Bakken Research Center
March 2013

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