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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Universität zu Köln
      • Magdeburg, Germany
        • Otto-von-Guericke-Universität Magdeburg
      • München, Germany
        • Klinikum Rechts Der Isar Der Technischen Universität München
      • Osnabrück, Germany
        • Niels-Stensen-Kliniken Marienhospital Osnabrück
      • Ulm, Germany
        • Universitatsklinikum 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
        • Policlinico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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