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

December 7, 2021 updated by: Abbott Medical Devices

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1041

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Nauheim, Germany
        • Kerckhoff-Klinik gGmbH
      • Berlin, Germany
        • Deutsches Herzzentrum Berlin
      • Bernau, Germany
        • Immanuelklinikum Bernau und Herzzentrum Brandenburg
      • Dortmund, Germany
        • St.-Johannes-Hospital
      • Düsseldorf, Germany
        • Medizinische Einrichtungen der Universität Düsseldorf
      • Gießen, Germany
        • Klinikum der Justus-Liebig-Universität
      • Göttingen, Germany
        • Universitätsmedizin Göttingen Georg-August-Universität
      • Hamburg, Germany, 22087
        • Katholisches Marienkrankenhaus GmbH
      • Heidelberg, Germany
        • Klinikum der Ruprecht-Karls-Universität Heidelberg
      • Karlsburg, Germany
        • Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG.
      • Köln, Germany
        • Medizinische Einrichtungen der Universitat zu Koln
      • Magdeburg, Germany
        • Otto-von-Guericke-Universität Magdeburg
      • München, Germany
        • Klinikum rechts der Isar der Technischen Universitat Munchen
      • Osnabrück, Germany
        • Niels-Stensen-Kliniken Marienhospital Osnabrück
      • Ulm, Germany
        • Universitätsklinikum Ulm
    • Bavaria
      • München, Bavaria, Germany, 81377
        • München Grosshadern
    • Rhinela
      • Mainz, Rhinela, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Saxony
      • Leipzig, Saxony, Germany, 04289
        • Herzzentrum Leipzig GmbH
  • Israel
      • Jerusalem, Israel
        • Shaare Zedek Medical Center
      • Jerusalem, Israel
        • Hadassah - Ein Kerem
  • Italy
      • Milan, Italy
        • Centro Cardiologico Monzino
    • Lombard
      • Milano, Lombard, Italy, 20132
        • Ospedale San Raffaele
      • Milano, Lombard, Italy, 20132
        • Ospedale San Raffaele- Cardiac
      • Milano, Lombard, Italy, 20132
        • Policlínico San Donato
    • Sicilia
      • Catania, Sicilia, Italy, 95124
        • Presidio Ospedaliero Ferrarotto Alessi
  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis
      • Utrecht, Netherlands
        • UMC Utrecht
  • Spain
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Madrid, Spain
        • Hospital Puerta de Hierro - Hospital Universitario
      • Málaga, Spain
        • HCU Virgen de la Victoria
  • Switzerland
      • Aarau, Switzerland
        • Kantonsspital
      • Bern, Switzerland, 3010
        • Inselspital - University Hospital of Bern
      • Zürich, Switzerland, 8091
        • Universitaets Spital Zuerich
  • United Kingdom
      • London, United Kingdom
        • Royal Brompton Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Baptist Medical Center Princeton
    • Arizona
      • Phoenix, Arizona, United States, 85001
        • Phoenix Cardiovascular Research Group
    • California
      • La Jolla, California, United States, 92037
        • Scripps Health
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Sacramento, California, United States, 95817
        • University of California - Davis Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80309
        • University of Colorado Hospital
    • Florida
      • West Palm Beach, Florida, United States, 33401
        • JFK Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60007
        • Northwestern Memorial Hospital
    • Kansas
      • Kansas City, Kansas, United States, 67218
        • Via Christi Regional Medical Center - St. Francis Campus
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64102
        • St. Luke's Hospital
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health System - Morristown Memorial Hospital
    • New York
      • New York, New York, United States, 10016
        • New York University Hospital
      • New York, New York, United States, 10001
        • New York-Presbyterian/Columbia University Medical Center
      • New York, New York, United States, 10011
        • Mount Sinai Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 41073
        • Christ Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37236
        • St. Thomas Hospital
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Medical Center
      • Norfolk, Virginia, United States, 23504
        • Sentara Norfolk General Hospital
    • Washington
      • Seattle, Washington, United States, 98101
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study will include patients who will undergo commercial procedures with the MitraClip® NTR System and/or MitraClip® XTR System after required approval of the device is obtained.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR and XTR system
Device: MitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR/XTR system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At 30 Days
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.
At 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

Abbott

Investigators

  • Principal Investigator: Dr. Saibal Kar, MD, Cedars Sinai, Los Angeles CA
  • Principal Investigator: Prof. Francesco Maisano, MD, University Hospital, Zürich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2018

Primary Completion (Actual)

April 5, 2019

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (Actual)

April 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-518

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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