Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation (DYANA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by MiCardia Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
MiCardia Corporation
ClinicalTrials.gov Identifier:
NCT00833014
First received: January 8, 2009
Last updated: January 29, 2009
Last verified: January 2009
  Purpose

The device is a dynamic annuloplasty ring/band that is able to be adjusted in order to correct for mitral regurgitation intraoperatively or postoperatively, off-pump.


Condition Intervention Phase
Mitral Valve Regurgitation
Device: Dynamic Annuloplasty Ring (with option to adjust off-pump)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation

Further study details as provided by MiCardia Corporation:

Primary Outcome Measures:
  • Freedom from major complications and SAM (Systolic Anterior Motion) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ability to adjust annuloplasty ring off-pump post implantation to correct for residual regurgitation, reduction of mitral valve regurgitation at follow-up visits (discharge, 30 days, 6 months) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: December 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I Device: Dynamic Annuloplasty Ring (with option to adjust off-pump)
Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. This patient requires mitral valve repair with or without concomitant procedures such as coronary artery bypass or another valve reconstruction or replacement.
  2. This patient has been diagnosed with a diseased natural valve, based on echocardiography and is a candidate for mitral valve repair.
  3. This patient is in satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk. (i.e., likely to survive one year postoperatively).
  4. This patient is geographically stable and willing to return to the implant center for follow-up visits.
  5. This patient has been adequately informed of his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.

Exclusion Criteria:

  1. This patient is less than eighteen (18) years of age.
  2. This patient has a non-cardiac major or progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than twelve months.
  3. This patient has an ejection fraction < 30%.
  4. This patient has a heavily calcified annulus or leaflets.
  5. This patient presents with active endocarditis or has had active endocarditis in the last 3 months.
  6. This patient is pregnant (urine HCG test result positive) or lactating.
  7. This patient is an intravenous drug abuser or alcohol abuser.
  8. This patient has a previously implanted prosthetic mitral valve.
  9. This patient requires mitral valve replacement.
  10. This patient has a creatinine level > 2.0 mg/dl
  11. This patient has had congestive heart failure within the past 6 months requiring surgical treatment.
  12. This patient has had a coronary artery ischemic event within the past 6 months.
  13. This patient has a known life threatening, non-cardiac disease that will limit the patient's life expectancy to less than one year.
  14. This patient is unable to take Coumadin.
  15. This patient has a known untreatable allergy to contrast media or nickel.
  16. This patient has had a cerebral vascular event within the past 6 months.
  17. This patient is a prisoner (U.S.A. Only).
  18. This patient is participating in concomitant research studies of investigational products.
  19. This patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.
  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: NCT00833014

Contacts
Contact: Jody L Errandi, M.S. 949.951.4888 ext 12 jerrandi@micardia.com

Locations
Canada, British Columbia
University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V6Z1Y6
Contact: Kevin Schillitto    604-806-8383    KShillitto@providencehealth.bc.ca   
Principal Investigator: Jian Ye, MD         
Germany
University of Saarlands Recruiting
Homburg, Germany, 66421
Contact: Frank Langer, MD    06841/1632000    frank.langer@uks.eu   
Principal Investigator: H J Schafers, MD, PhD         
Universitatsklinikum Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Contact: Arne M Eide, MD    +1494315974400    eideam@hotmail.com   
Principal Investigator: Jochen Cremer, MD PhD         
University of Leipzig Herzzentrum Recruiting
Leipzig, Germany, 04289
Contact: Sissy Ott    +4903418651570    sissy.ott@herzzentrum-leipzig.de   
Netherlands
Erasmus MC Not yet recruiting
Rotterdam, Netherlands
Contact: Liesbeth Duininck    + 310107032150    e.duininck@erasmusmc.nl   
Principal Investigator: Pieter Kappetein, MD PhD         
Sponsors and Collaborators
MiCardia Corporation
  More Information

Additional Information:
Publications:

Responsible Party: Paul Molloy, CEO, MiCardia Corporation
ClinicalTrials.gov Identifier: NCT00833014     History of Changes
Other Study ID Numbers: TP07-006
Study First Received: January 8, 2009
Last Updated: January 29, 2009
Health Authority: EU: KEMA

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

ClinicalTrials.gov processed this record on August 28, 2014