The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices
A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip® Devices (EXPAND)
1 other identifier
observational
1,041
8 countries
57
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Typical duration for all trials
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2018
CompletedFirst Posted
Study publicly available on registry
April 19, 2018
CompletedStudy Start
First participant enrolled
April 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedResults Posted
Study results publicly available
February 16, 2022
CompletedFebruary 16, 2022
December 1, 2021
11 months
April 11, 2018
June 14, 2021
December 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety Measure: Number of Participants With Major Adverse Events (MAE)
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+
The performance was measured by Mitral Regurgitation (MR) Reduction to ≤2+ at 30-day visits.
At 30 days
Study Arms (1)
MitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR and XTR system
Interventions
Percutaneous mitral valve repair using the MitraClip NTR/XTR system.
Eligibility Criteria
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.
You may qualify if:
- 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+)
You may not qualify if:
- \. Subjects participating in another clinical study that may impact the follow-up or results of this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Medical Deviceslead
- Abbottcollaborator
Study Sites (57)
Baptist Medical Center Princeton
Birmingham, Alabama, 35211, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85001, United States
Scripps Health
La Jolla, California, 92037, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California - Davis Medical Center
Sacramento, California, 95817, United States
University of Colorado Hospital
Aurora, Colorado, 80309, United States
JFK Medical Center
West Palm Beach, Florida, 33401, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60007, United States
Via Christi Regional Medical Center - St. Francis Campus
Kansas City, Kansas, 67218, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
St. Luke's Hospital
Kansas City, Missouri, 64102, United States
Atlantic Health System - Morristown Memorial Hospital
Morristown, New Jersey, 07960, United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10001, United States
Mount Sinai Hospital
New York, New York, 10011, United States
New York University Hospital
New York, New York, 10016, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Christ Hospital
Cincinnati, Ohio, 41073, United States
St. Thomas Hospital
Nashville, Tennessee, 37236, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22903, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23504, United States
University of Washington Medical Center
Seattle, Washington, 98101, United States
München Grosshadern
München, Bavaria, 81377, Germany
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz
Mainz, Rhinela, 55131, Germany
Herzzentrum Leipzig GmbH
Leipzig, Saxony, 04289, Germany
Kerckhoff-Klinik gGmbH
Bad Nauheim, Germany
Deutsches Herzzentrum Berlin
Berlin, Germany
Immanuelklinikum Bernau und Herzzentrum Brandenburg
Bernau, Germany
Medizinische Einrichtungen der Universitat zu Koln
Cologne, Germany
St.-Johannes-Hospital
Dortmund, Germany
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf, Germany
Klinikum der Justus-Liebig-Universität
Giessen, Germany
Universitatsmedizin Gottingen Georg-August-Universitat
Göttingen, Germany
Katholisches Marienkrankenhaus GmbH
Hamburg, 22087, Germany
Klinikum der Ruprecht-Karls-Universität Heidelberg
Heidelberg, Germany
Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG.
Karlsburg, Germany
Otto-von-Guericke-Universität Magdeburg
Magdeburg, Germany
Klinikum Rechts Der Isar der Technischen Universitat Munchen
München, Germany
Niels-Stensen-Kliniken Marienhospital Osnabrück
Osnabrück, Germany
Universitatsklinikum Ulm
Ulm, Germany
Hadassah - Ein Kerem
Jerusalem, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Ospedale San Raffaele- Cardiac
Milan, Lombard, 20132, Italy
Ospedale San Raffaele
Milan, Lombard, 20132, Italy
Policlinico San Donato
Milan, Lombard, 20132, Italy
Presidio Ospedaliero Ferrarotto Alessi
Catania, Sicily, 95124, Italy
Centro Cardiologico Monzino
Milan, Italy
Catharina Ziekenhuis
Eindhoven, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
UMC Utrecht
Utrecht, Netherlands
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain
Hospital Puerta de Hierro - Hospital Universitario
Madrid, Spain
HCU Virgen de la Victoria
Málaga, Spain
Kantonsspital
Aarau, Switzerland
Inselspital - University Hospital of Bern
Bern, 3010, Switzerland
Universitaets Spital Zuerich
Zurich, 8091, Switzerland
Royal Brompton Hospital
London, United Kingdom
Related Publications (3)
Kar S, von Bardeleben RS, Rottbauer W, Mahoney P, Price MJ, Grasso C, Williams M, Lurz P, Ahmed M, Hausleiter J, Chehab B, Zamorano JL, Asch FM, Maisano F. Contemporary Outcomes Following Transcatheter Edge-to-Edge Repair: 1-Year Results From the EXPAND Study. JACC Cardiovasc Interv. 2023 Mar 13;16(5):589-602. doi: 10.1016/j.jcin.2023.01.010.
PMID: 36922046DERIVEDShuvy M, von Bardeleben RS, Grasso C, Raake P, Lurz P, Zamorano JL, Asch F, Kar S, Maisano F; EXPAND Investigators. Safety and efficacy of MitraClip in acutely ill (NYHA Class IV) patients with mitral regurgitation: Results from the global EXPAND study. ESC Heart Fail. 2023 Apr;10(2):1122-1132. doi: 10.1002/ehf2.14273. Epub 2023 Jan 4.
PMID: 36599332DERIVEDSodhi N, Asch FM, Ruf T, Petrescu A, von Bardeleben RS, Lim DS, Maisano F, Kar S, Price MJ. Clinical Outcomes With Transcatheter Edge-to-Edge Repair in Atrial Functional MR From the EXPAND Study. JACC Cardiovasc Interv. 2022 Sep 12;15(17):1723-1730. doi: 10.1016/j.jcin.2022.07.023.
PMID: 36075643DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nadia Bouhdi
- Organization
- Abbott
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Saibal Kar, MD
Cedars Sinai, Los Angeles CA
- PRINCIPAL INVESTIGATOR
Prof. Francesco Maisano, MD
University Hospital, Zürich
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2018
First Posted
April 19, 2018
Study Start
April 26, 2018
Primary Completion
April 5, 2019
Study Completion
December 31, 2020
Last Updated
February 16, 2022
Results First Posted
February 16, 2022
Record last verified: 2021-12