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Clinical Trials/NL-OMON50054
NL-OMON50054
Withdrawn
Not Applicable

A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients with Functional Mitral Regurgitation - Millipede Feasibility Study

Boston Scientific Cooperation International0 sites10 target enrollmentTBD
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Conditionsrepair of the mitral valve - a backflow of blood within the heart due to the failure of the mitral valve to close properly10046973

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
repair of the mitral valve - a backflow of blood within the heart due to the failure of the mitral valve to close properly
Sponsor
Boston Scientific Cooperation International
Enrollment
10
Status
Withdrawn
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Boston Scientific Cooperation International

Eligibility Criteria

Inclusion Criteria

  • •IC1: Subject is 18 Years of age or older
  • •IC2: Subject (or legal guardian) understands the trial requirements and the
  • •treatment procedures and provides informed consent before any trial \-specific
  • •tests or procedures are performed
  • •IC3: Subject has moderate to severe (3\+) or severe (4\+) functional mitral
  • •regurgitation(a) confirmed by the echocardiography core lab.
  • •IC4: Subject is symptomatic (NYHA Class II\-IV) despite guidelines directed
  • •medical therapy, including CRT if indicated
  • •IC5\. The local site heart team concurs that mitral valve surgery will not be
  • •offered as a first\-line treatment option

Exclusion Criteria

  • •EC1\. Subject has severe calcification of the mitral annulus or leaflets, other
  • •anatomic features that makes the patient unsuitable for annuloplasty with the
  • •Millipede System in the judgment of the treating physician or subject does not
  • •have suitable mitral annular diameter (determined by computed tomography) as
  • •per the Instructions For Use).
  • •EC2\. Transfemoral venous and transseptal access determined not to be feasible
  • •EC3\. Subject is on the waiting list for a transplant or has had a prior heart
  • •EC4\. Subject has had a cerebrovascular accident (CVA) or transient ischemic
  • •attack (TIA) within 30 days prior to study enrollment
  • •EC5\. Subject has had any percutaneous coronary, carotid, or other endovascular

Outcomes

Primary Outcomes

Not specified

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