Status:
UNKNOWN
Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation
Lead Sponsor:
MiCardia Corporation
Conditions:
Mitral Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- This patient requires mitral valve repair with or without concomitant procedures such as coronary artery bypass or another valve reconstruction or replacement.
- This patient has been diagnosed with a diseased natural valve, based on echocardiography and is a candidate for mitral valve repair.
- 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).
- This patient is geographically stable and willing to return to the implant center for follow-up visits.
- 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
- This patient is less than eighteen (18) years of age.
- 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.
- This patient has an ejection fraction \< 30%.
- This patient has a heavily calcified annulus or leaflets.
- This patient presents with active endocarditis or has had active endocarditis in the last 3 months.
- This patient is pregnant (urine HCG test result positive) or lactating.
- This patient is an intravenous drug abuser or alcohol abuser.
- This patient has a previously implanted prosthetic mitral valve.
- This patient requires mitral valve replacement.
- This patient has a creatinine level \> 2.0 mg/dl
- This patient has had congestive heart failure within the past 6 months requiring surgical treatment.
- This patient has had a coronary artery ischemic event within the past 6 months.
- This patient has a known life threatening, non-cardiac disease that will limit the patient's life expectancy to less than one year.
- This patient is unable to take Coumadin.
- This patient has a known untreatable allergy to contrast media or nickel.
- This patient has had a cerebral vascular event within the past 6 months.
- This patient is a prisoner (U.S.A. Only).
- This patient is participating in concomitant research studies of investigational products.
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00833014
Start Date
December 1 2008
End Date
December 1 2010
Last Update
January 30 2009
Active Locations (5)
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1
University of British Columbia
Vancouver, British Columbia, Canada, V6Z1Y6
2
University of Saarlands
Homburg, Germany, 66421
3
Universitatsklinikum Schleswig-Holstein
Kiel, Germany, 24105
4
University of Leipzig Herzzentrum
Leipzig, Germany, 04289