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NCT03502811 Clinical Trial

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

Mitral Regurgitation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03502811
Other study ID # 17-518
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 26, 2018
Est. completion date December 31, 2020

Study information
Verified date December 2021
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 1041
Est. completion date December 31, 2020
Est. primary completion date April 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• MitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR/XTR system.

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

Sponsors (2)
Lead Sponsor Collaborator
Abbott Medical Devices Abbott

Countries where clinical trial is conducted

United States,  Germany,  Israel,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
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Completed NCT05836532 - Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
Recruiting NCT03975998 - Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation
Completed NCT01162083 - Identifying an Ideal Cardiopulmonary Exercise Test Parameter N/A
Suspended NCT00787293 - Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients Phase 2