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Completed

NCT Number: NCT03502811

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

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.

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Key information

Conditions

Mitral Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Regurgitation Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

München Grosshadern, München, Bavaria, Germany

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About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who give consent for their participation
  • Subjects scheduled to receive the MitraClip per the current approved indications for use
  • Subjects with Symptomatic MR (≥3+)

Exclusion criteria

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

Treatment and study plan

MitraClip NTR/XTR System

Device

Percutaneous mitral valve repair using the MitraClip NTR/XTR system.

Primary outcomes

  1. Safety Measure: Number of Participants With Major Adverse Events (MAE)

    Time frame: At 30 Days

    MAE was defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications (CEC adjudicated).

  2. Performance Measure: Number of Participants With Mitral Regurgitation (MR) Reduction to ≤2+

    Time frame: At 30 days

    The performance was measured by Mitral Regurgitation (MR) Reduction to ≤2+ at 30-day visits.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • Abbott

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 19, 2018
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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