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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02607527
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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

Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Device: Mitral Valve IRIS Ring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : January 17, 2019
Actual Study Completion Date : December 19, 2019

Arm Intervention/treatment
Device Implantation
Transcatheter IRIS placement
Device: Mitral Valve IRIS Ring
Transcatheter implantation of the IRIS




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Efficacy assessed by reduction in mitral regurgitation without significant mitral stenosis as measured by echo [ Time Frame: Procedural through 48 hrs post procedure ]
    Reduction in mitral regurgitation to optimal or acceptable levels without significant mitral stenosis post procedure (defined as discharge or 48 hrs whichever comes first) and EROA <1.5 cm2 with transmitral gradient <5mm Hg as compared to screening echo



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Tricuspid valve disease requiring surgery.
  • Aortic valve disease requiring surgery or TAVI.
  • Carotid surgery within 30 days prior to subject registration.
  • Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac -Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30 days prior to subject registration.
  • Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
  • Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure.
  • Status 1 heart transplant or prior orthotopic heart transplantation.
  • Chronic Kidney Disease.
  • Chronic Steroid Therapy.
  • Cerebrovascular accident within 30 days prior to subject's consent.
  • Severe symptomatic carotid stenosis (> 70% by ultrasound).Life expectancy < 12 months due to non-cardiac conditions.
  • Active infections requiring current antibiotic therapy.
  • Pregnant or planning pregnancy within next 12 months.
  • Currently participating in an investigational drug or another device study.
  • Severe organic lesions with mitral chords retraction, severely fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
  • endocarditis or active endocarditis in the last 3 months.
  • Heavily calcified annulus or leaflets, mitral valve stenosis.
  • Congenital malformation with limited valvular tissue
  • Patient requires mitral valve replacement
  • Previously implanted prosthetic mitral valve or annuloplasty ring/band.
  • Evidence of LV or LA thrombus, vegetation or mass
  • Left Ventricular Ejection Fraction <20%
  • Left Ventricular End Diastolic Diameter >65 mm
  • Severe tricuspid regurgitation or severe RV dysfunction
  • Condition that prevents transatrial access or transfemoral access
  • Anatomical ineligibility to the investigational device
  • Known hypersensitivity or contraindication to procedural or post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607527


Locations
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Brazil
Dante Pazzanese de Cardiologia
São Paulo, Brazil, 04012-909
Paraguay
Sanatorio Italiano
Asunción, Paraguay, 1023
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Alexandre Abizaid, MD Dante Pazzanese de Cardiologia
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02607527    
Other Study ID Numbers: CP-002, CP-003
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases