NCT03502811

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

A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip® Devices (EXPAND)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,041 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Mitral Valve Regurgitation
• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	MitraClip NTR/XTR System	Percutaneous mitral valve repair using the MitraClip NTR/XTR system.

Timeline

• Start date: 2018-04-26
• Primary completion: 2019-04-05
• Completion: 2020-12-31
• First posted: 2018-04-19
• Last updated: 2022-02-16
• Results posted: 2022-02-16

Locations

57 sites across 8 countries: United States, Germany, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom