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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
History of Changes

January 8, 2009
January 29, 2009
December 2008
December 2010   (final data collection date for primary outcome measure)
Freedom from major complications and SAM (Systolic Anterior Motion) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00833014 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation
Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mitral Valve Regurgitation
Device: Dynamic Annuloplasty Ring (with option to adjust off-pump)
Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant.
Experimental: I
Intervention: Device: Dynamic Annuloplasty Ring (with option to adjust off-pump)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Jody L Errandi, M.S. 949.951.4888 ext 12 jerrandi@micardia.com
Canada,   Germany,   Netherlands
 
NCT00833014
TP07-006
No
Paul Molloy, CEO, MiCardia Corporation
MiCardia Corporation
Not Provided
Not Provided
MiCardia Corporation
January 2009

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