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

NCT02607527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-10-24

No results posted yet for this study

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

Interventions

DEVICE

Mitral Valve IRIS Ring

Transcatheter implantation of the IRIS

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Alexandre Abizaid, MD · Dante Pazzanese de Cardiologia

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2019-01-17
Completion
2019-12-19
FDA Device
Yes

Countries

  • Brazil
  • Paraguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02607527 on ClinicalTrials.gov