Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation

Study Overview
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Brief Summary
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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.

Official Title
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Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation

Conditions
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Mitral Valve Regurgitation

Intervention / Treatment
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* Device: Dynamic Annuloplasty Ring (with option to adjust off-pump)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br> | Device: Dynamic Annuloplasty Ring (with option to adjust off-pump)<br>* Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) |  | 6 months |