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

NCT02607527 | Completed FDA Device

• 1 other identifier: CP-002, CP-003
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

• Acute Safety defined as incidence of adverse events

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

  Procedure through 30 days post procedure

Secondary Outcomes (1)

• Efficacy assessed by reduction in mitral regurgitation without significant mitral stenosis as measured by echo

  Procedural through 48 hrs post procedure

Study Arms (1)

Device Implantation

OTHER

Transcatheter IRIS placement

Device: Mitral Valve IRIS Ring

Interventions

Mitral Valve IRIS Ring DEVICE

Transcatheter implantation of the IRIS

Device Implantation

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

Dante Pazzanese de Cardiologia

São Paulo, 04012-909, Brazil

Location

Sanatorio Italiano

Asunción, 1023, Paraguay

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Alexandre Abizaid, MD

  Dante Pazzanese de Cardiologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: November 18, 2015
• Study Start: May 8, 2017
• Primary Completion: January 17, 2019
• Study Completion: December 19, 2019
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

PA (1); BR (1)