Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System

Boston Scientific Corporation2 sites in 2 countries21 target enrollmentMay 8, 2017

ConditionsMitral Valve Insufficiency

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mitral Valve Insufficiency
Sponsor: Boston Scientific Corporation
Enrollment: 21
Locations: 2
Primary Endpoint: Acute Safety defined as incidence of adverse events
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.

Detailed Description

Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery. This trial is designed in accordance with the 2014 ACC/AHA guidelines for valvular heart disease, and the consensus statement of MVARC 2015. Subjects will undergo transcatheter implantation of the Millipede IRIS implant.

Registry

clinicaltrials.gov

Start Date

May 8, 2017

End Date

December 19, 2019

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Presence of symptomatic severe MR (effective regurgitant orifice (ERO) ≥0.2 cm2 for Secondary MR, ERO ≥0.4 cm2 for Primary MR)
•The New York Heart Association Functional Class II, III or ambulatory IV.
•Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50%
•Creatine Kinase-MB (CK-MB) obtained within prior 14 days \< local laboratory -Upper Limit of Normal (ULN).
•Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by TTE obtained within 90 days

Exclusion Criteria

•Untreated clinically significant coronary artery disease requiring revascularization.
•Presence of any of the following:
•Estimated pulmonary artery systolic pressure (PASP) \> 70 mmHg assessed by site based on echocardiography or right heart catheterization
•Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
•Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
•Hemodynamic instability requiring inotropic support or mechanical heart assistance.
•Hemodynamic instability defined as systolic pressure \< 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
•Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.
•Coronary artery bypass grafting (CABG) within 30 days prior to subject's consent.
•Percutaneous coronary intervention within 30 days prior to subject's consent.

Outcomes

Primary Outcomes

Acute Safety defined as incidence of adverse events

Time Frame: Procedure through 30 days post procedure

30 days defined as ability to implant, anchor and actuate without incidence of adverse events

Secondary Outcomes

Efficacy assessed by reduction in mitral regurgitation without significant mitral stenosis as measured by echo(Procedural through 48 hrs post procedure)