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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 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: April 28, 2015
Last verified: April 2015
  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
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 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

  • 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


Estimated Enrollment: 85
Study Start Date: September 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: February 2016 (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
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

Contacts
Contact: Marieke Gerards +31 43 356 6594 marieke.gerards@medtronic.com
Contact: Patrick Simons +31 43 356 6794 patrick.simons@medtronic.com

Locations
France
Hôpital de Lyon - Hôpital Louis Pradel Recruiting
Lyon, France, 69500
Contact: Jean Francois Obadia, Prof. Dr.         
Centre Hospitalier de Mulhouse Recruiting
Mulhouse, France, 68100
Contact: Nicolas Bischoff, Dr.         
Germany
Albertinen Herz- und Gefäßzentrum Recruiting
Hamburg, Germany, 22457
Contact: Friedrich-Christian Rieß, Prof. Dr.         
Universitätsklinikum Schleswig-Holstein Recruiting
Lübeck, Germany, 23562
Contact: Thorsten Hanke, Dr         
Deutsches Herzzentrum München Recruiting
Munich, Germany, D-80636
Contact: Ralf Guenzinger, Dr.         
Israel
Soroka Medical Center Recruiting
Be'er Sheeva, Israel, 84101
Contact: Gideon Sahar, Prof. Dr.         
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Dani Bitran, Prof. Dr.         
Netherlands
Leids Universitair Medical Center (LUMC) Not yet recruiting
Leiden, Netherlands, 2333
Contact: Robert Klautz, Prof. Dr.         
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: April 28, 2015
Health Authority: Germany: Central and institutional Ethics Commissions
France: Conseil National de l'Ordre des Médecins
Israel: Institutional Medical Ethics Commissions
The Netherlands: Institutional Scientific Committee and Institutional Ethics Commission

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

ClinicalTrials.gov processed this record on May 21, 2015