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Clinical Trials/NL-OMON39112
NL-OMON39112
Completed
Phase 2

A Study of Percutaneous Left Ventricular Reshaping of Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve LV Function Using the Accucinch System. - LV Restore Study

Guided Delivery Systems, Inc.0 sites10 target enrollmentTBD
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Conditionsfunctional mitral regurgitationheart failure10046973

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
functional mitral regurgitation
Sponsor
Guided Delivery Systems, Inc.
Enrollment
10
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Guided Delivery Systems, Inc.

Eligibility Criteria

Inclusion Criteria

  • •1\. Age \>\= 18 years
  • •2\. Subjects with clinically significant mitral regurgitation (MR 2\+ and above)
  • •3\. Ejection Fraction \>\= 25%
  • •4\. Stable cardiac medical regimen for heart failure for at least 1 month
  • •5\. Stable NYHA Classification for at least 1 month
  • •6\. Subject is eligible for cardiac surgery
  • •7\. The subject has been informed of the nature of the study, agrees to its provisions, and has provided written consent

Exclusion Criteria

  • •1\. Myocardial infarction within 90 days of the intended treatment with the device
  • •2\. Prior surgical, transcatheter, or percutaneous mitral valve intervention
  • •3\. Any intervention for coronary artery disease (CAD) within the last 30 days prior to treatment, or unrevascularized multivessel coronary disease.
  • •4\. Hemodynamic instability or the need for emergent surgery
  • •5\. Non\-ambulatory NYHA Class IV symptoms of heart failure or subjects requiring IV inotropic support
  • •6\. Subjects in whom sufficient quality of echocardiography (TTE and TEE) cannot be obtained
  • •7\. Echocardiography evidence of primary mitral valve disease causing MR or MS
  • •8\. Evidence of mitral valve stenosis with an estimated valve area less than 3\.0 cm²
  • •9\. Mitral valve prosthesis or pathology that would prevent adequate function of the GDS Accucinch System
  • •10\. Estimated GFR of \<30ml/min/1\.73m²

Outcomes

Primary Outcomes

Not specified

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