The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices

Status Completed

Clinical Trial Summary

The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR System.

Clinical Trial Description

The data collected in this study will be used to evaluate device outcomes and characterize trends in patient selection for MitraClip therapy in contemporary real-world use. Moreover, the data will be assessed to identify patient or mitral valve anatomical characteristics that may be most appropriate for these next generation devices. The MitraClip EXPAND Study will be conducted on commercial MitraClip NTR System and MitraClip XTR System that have received CE Mark and/or FDA approval as required. Up to 1,000 subjects at a maximum of 60 sites in Europe and the US were initially planned to enroll in the MitraClip EXPAND Study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03502811
Study type	Observational
Source	Abbott Medical Devices
Contact
Status	Completed
Phase
Start date	April 26, 2018
Completion date	December 31, 2020

View Details

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