The MitraClip® EXPAND Study

Status:	Recruiting
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	11/9/2018
Start Date:	April 26, 2018
End Date:	January 31, 2020
Contact:	Leslie Ornelas
Email:	leslie.ornelas@abbott.com
Phone:	408-306-7436

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

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.

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.

Inclusion Criteria:

1. Subjects who give consent for study procedure

2. Subjects eligible to receive the MitraClip per the current approved indications for
use

3. Subjects with Symptomatic MR (≥3+)

Exclusion Criteria:

1. Subjects participating in another clinical study that may impact the follow-up or
results of this study

We found this trial at

sites

Carolinas Medical Center

1000 Blythe Blvd
Charlotte, North Carolina 28203

(704) 355-2000