The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Mitral Regurgitation
- Mitral Valve Regurgitation
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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. Clinical outcomes and Echocardiographic measures will be assessed in the context of historical data. The MitraClip EXPAND Study...
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. Clinical outcomes and Echocardiographic measures will be assessed in the context of historical data. 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 will be in the MitraClip EXPAND Study.
Tracking Information
- NCT #
- NCT03502811
- Collaborators
- Abbott
- Investigators
- Principal Investigator: Dr. Saibal Kar, MD Cedars Sinai, Los Angeles CA Principal Investigator: Prof. Francesco Maisano, MD University Hospital, Zürich
Get Well Soon