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

January 29, 2009 updated by: MiCardia Corporation
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z1Y6
        • Not yet recruiting
        • University of British Columbia
        • Contact:
        • Principal Investigator:
          • Jian Ye, MD
  • Germany
      • Homburg, Germany, 66421
        • Recruiting
        • University of Saarlands
        • Contact:
        • Principal Investigator:
          • H J Schafers, MD, PhD
      • Kiel, Germany, 24105
        • Recruiting
        • Universitatsklinikum Schleswig-Holstein
        • Contact:
        • Principal Investigator:
          • Jochen Cremer, MD PhD
      • Leipzig, Germany, 04289
  • Netherlands
      • Rotterdam, Netherlands
        • Not yet recruiting
        • Erasmus MC
        • Contact:
        • Principal Investigator:
          • Pieter Kappetein, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from major complications and SAM (Systolic Anterior Motion)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MiCardia Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

January 30, 2009

Study Record Updates

Last Update Posted (Estimate)

January 30, 2009

Last Update Submitted That Met QC Criteria

January 29, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP07-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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