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

Abbott

Status: Completed

Conditions: Mitral Valve Regurgitation; Mitral Regurgitation

Treatments: Device: MitraClip NTR/XTR System

Study type: Observational

Funder types: Industry

Identifiers

NCT03502811

17-518

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,041 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects who give consent for their participation
2. Subjects scheduled 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

Trial design

1,041 participants in 1 patient group

MitraClip NTR/XTR System

Description:

Percutaneous mitral valve repair using the MitraClip NTR and XTR system

Treatment:

Device: MitraClip NTR/XTR System