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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00833014
Recruitment Status : Unknown
Verified January 2009 by MiCardia Corporation.
Recruitment status was:  Recruiting
First Posted : January 30, 2009
Last Update Posted : January 30, 2009
Information provided by:
MiCardia Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Mitral Valve Regurgitation Device: Dynamic Annuloplasty Ring (with option to adjust off-pump) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation
Study Start Date : December 2008
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Freedom from major complications and SAM (Systolic Anterior Motion) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00833014

Contact: Jody L Errandi, M.S. 949.951.4888 ext 12

Canada, British Columbia
University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V6Z1Y6
Contact: Kevin Schillitto    604-806-8383   
Principal Investigator: Jian Ye, MD         
University of Saarlands Recruiting
Homburg, Germany, 66421
Contact: Frank Langer, MD    06841/1632000   
Principal Investigator: H J Schafers, MD, PhD         
Universitatsklinikum Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Contact: Arne M Eide, MD    +1494315974400   
Principal Investigator: Jochen Cremer, MD PhD         
University of Leipzig Herzzentrum Recruiting
Leipzig, Germany, 04289
Contact: Sissy Ott    +4903418651570   
Erasmus MC Not yet recruiting
Rotterdam, Netherlands
Contact: Liesbeth Duininck    + 310107032150   
Principal Investigator: Pieter Kappetein, MD PhD         
Sponsors and Collaborators
MiCardia Corporation

Additional Information:
Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):e21-181. doi: 10.1161/CIRCULATIONAHA.108.191261. Epub 2008 Dec 15. Erratum in: Circulation. 2011 Oct 18;124(16):e424. Circulation. 2010 Jul 6;122(1):e11. Circulation. 2009 Jan 27;119(3):e182.

Responsible Party: Paul Molloy, CEO, MiCardia Corporation Identifier: NCT00833014     History of Changes
Other Study ID Numbers: TP07-006
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: January 30, 2009
Last Verified: January 2009

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