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
  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 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.


Condition
Evaluate the Hemodynamic Performance

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 Bakken Research Center:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 85
Study Start Date: September 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: March 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532921

Contacts
Contact: Anneleen Daniels +31 43 356 6789 anneleen.daniels@medtronic.com
Contact: Ber Kleijnen +31 43 356 6812 ber.kleijnen@medtronic.com

Locations
Germany
Deutsches Herzzentrum München Recruiting
Munich, Germany, D-80636
Contact: Ralf Guenzinger, Dr.       guenzinger@dhm.mhn.de   
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Rüdiger Lange, Prof. Dr. med. Deutsches Herzzentrum München
  More Information

No publications provided

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: March 23, 2013
Health Authority: Germany: Ethics Commission
France: Conseil National de l'Ordre des Médecins
United Kingdom: Research Ethics Committee
United Kingdom: National Health Service
Austria: Ethikkommission

ClinicalTrials.gov processed this record on April 15, 2014