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
|Condition or disease||Intervention/treatment||Phase|
|Mitral Valve Insufficiency||Device: Mitral Valve IRIS Ring||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|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|
Transcatheter IRIS placement
Device: Mitral Valve IRIS Ring
Transcatheter implantation of the IRIS
- 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
- 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
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
|Dante Pazzanese de Cardiologia|
|São Paulo, Brazil, 04012-909|
|Asunción, Paraguay, 1023|
|Principal Investigator:||Alexandre Abizaid, MD||Dante Pazzanese de Cardiologia|