Clinical trial NCT00833014: Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation
Official title: Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Mitral Valve Regurgitation
Lead sponsor: MiCardia Corporation
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Freedom from major complications and SAM (Systolic Anterior Motion)
timeFrame: 6 months
Secondary outcomes:
measure: 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)
timeFrame: 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Homburg
country: Germany
facility: University of Saarlands
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: Leipzig
country: Germany
facility: University of Leipzig Herzzentrum
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
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