Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation

Phase 2

• Conditions: Mitral Valve Regurgitation
• Interventions: Device: Dynamic Annuloplasty Ring (with option to adjust off-pump)

• Registration Number: NCT00833014
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Status Verified: 2009-01
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-29
• Last Update Submitted: 2009-01-29
• Study First Posted: 2009-01-30
• Last Update Posted: 2009-01-30
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I	Dynamic Annuloplasty Ring (with option to adjust off-pump)	-

Primary Outcome Measures

Name	Time	Method
Freedom from major complications and SAM (Systolic Anterior Motion)	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Universitatsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Germany

University of Saarlands; 🇩🇪 Homburg, Germany

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

University of Leipzig Herzzentrum; 🇩🇪 Leipzig, Germany