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

Completed

Conditions: Mitral Valve Regurgitation
Mitral Regurgitation

Interventions: Device: MitraClip NTR/XTR System

Registration Number: NCT03502811

Lead Sponsor: Abbott Medical Devices

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1041

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MitraClip NTR/XTR System	MitraClip NTR/XTR System	Percutaneous mitral valve repair using the MitraClip NTR and XTR system

Primary Outcome Measures

Name	Time	Method
Safety Measure: Number of Participants With Major Adverse Events (MAE)	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).
Performance Measure: Number of Participants With Mitral Regurgitation (MR) Reduction to ≤2+	At 30 days	The performance was measured by Mitral Regurgitation (MR) Reduction to ≤2+ at 30-day visits.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (57): HCU Virgen de la Victoria
🇪🇸
Málaga, Spain
JFK Medical Center
🇺🇸
West Palm Beach, Florida, United States
Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
Via Christi Regional Medical Center - St. Francis Campus
🇺🇸
Kansas City, Kansas, United States
Baptist Medical Center Princeton
🇺🇸
Birmingham, Alabama, United States
Phoenix Cardiovascular Research Group
🇺🇸
Phoenix, Arizona, United States
Abbott Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
St. Thomas Hospital
🇺🇸
Nashville, Tennessee, United States
University of Colorado Hospital
🇺🇸
Aurora, Colorado, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Scripps Health
🇺🇸
La Jolla, California, United States
University of California - Davis Medical Center
🇺🇸
Sacramento, California, United States
St. Luke's Hospital
🇺🇸
Kansas City, Missouri, United States
Atlantic Health System - Morristown Memorial Hospital
🇺🇸
Morristown, New Jersey, United States
New York-Presbyterian/Columbia University Medical Center
🇺🇸
New York, New York, United States
New York University Hospital
🇺🇸
New York, New York, United States
Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States
University of Virginia Medical Center
🇺🇸
Charlottesville, Virginia, United States
Intermountain Medical Center
🇺🇸
Murray, Utah, United States
Deutsches Herzzentrum Berlin
🇩🇪
Berlin, Germany
München Grosshadern
🇩🇪
München, Bavaria, Germany
Herzzentrum Leipzig GmbH
🇩🇪
Leipzig, Saxony, Germany
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz
🇩🇪
Mainz, Rhinela, Germany
Kerckhoff-Klinik gGmbH
🇩🇪
Bad Nauheim, Germany
Immanuelklinikum Bernau und Herzzentrum Brandenburg
🇩🇪
Bernau, 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
Klinikum Rechts Der Isar der Technischen Universitat Munchen
🇩🇪
München, Germany
Policlinico San Donato
🇮🇹
Milano, Lombard, Italy
Klinikum der Ruprecht-Karls-Universität Heidelberg
🇩🇪
Heidelberg, Germany
Katholisches Marienkrankenhaus GmbH
🇩🇪
Hamburg, Germany
Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG.
🇩🇪
Karlsburg, Germany
Medizinische Einrichtungen der Universitat zu Koln
🇩🇪
Köln, Germany
Niels-Stensen-Kliniken Marienhospital Osnabrück
🇩🇪
Osnabrück, Germany
Otto-von-Guericke-Universität Magdeburg
🇩🇪
Magdeburg, Germany
Universitatsklinikum Ulm
🇩🇪
Ulm, Germany
Hadassah - Ein Kerem
🇮🇱
Jerusalem, Israel
Ospedale San Raffaele- Cardiac
🇮🇹
Milano, Lombard, Italy
Ospedale San Raffaele
🇮🇹
Milano, Lombard, Italy
Centro Cardiologico Monzino
🇮🇹
Milan, Italy
Presidio Ospedaliero Ferrarotto Alessi
🇮🇹
Catania, Sicilia, 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
Inselspital - University Hospital of Bern
🇨🇭
Bern, Switzerland
Kantonsspital
🇨🇭
Aarau, Switzerland
Universitaets Spital Zuerich
🇨🇭
Zürich, Switzerland
Mount Sinai Hospital
🇺🇸
New York, New York, United States
Shaare Zedek Medical Center
🇮🇱
Jerusalem, Israel
Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States
Royal Brompton Hospital
🇬🇧
London, United Kingdom