Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation

NCT00833014 | Unknown Phase 2

• 1 other identifier: TP07-006
• Study Type: interventional
• Target: 130
• Locations: 3 countries
• Sites: 5

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.

Conditions

Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

• Freedom from major complications and SAM (Systolic Anterior Motion)

  6 months

Secondary Outcomes (1)

• 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

Study Arms (1)

I

EXPERIMENTAL

Device: Dynamic Annuloplasty Ring (with option to adjust off-pump)

Interventions

Dynamic Annuloplasty Ring (with option to adjust off-pump) DEVICE

Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant.

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MiCardia Corporation: lead

Study Sites (5)

University of British Columbia

Vancouver, British Columbia, V6Z1Y6, Canada

NOT YET RECRUITING

University of Saarlands

Homburg, 66421, Germany

RECRUITING

Universitatsklinikum Schleswig-Holstein

Kiel, 24105, Germany

RECRUITING

University of Leipzig Herzzentrum

Leipzig, 04289, Germany

RECRUITING

Erasmus MC

Rotterdam, Netherlands

NOT YET RECRUITING

Related Publications (23)

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Related Links

• Related Info

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Jody L Errandi, M.S.

CONTACT

949.951.4888; jerrandi@micardia.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 30, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 30, 2009

Record last verified: 2009-01

Locations

DE (3); NL (1); CA (1)