Clinical trial NCT03502811: The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices
Official title: A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip® Devices (EXPAND)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Regurgitation
Mitral Regurgitation
Keywords: MitraClip
MitraClip NTR
MitraClip XTR
Mitral Regurgitation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Abbott
First posted: 2018-04-19
Enrollment: 1041
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety Measure: Number of Participants With Major Adverse Events (MAE)
timeFrame: At 30 Days
measure: Performance Measure: Number of Participants With Mitral Regurgitation (MR) Reduction to ≤2+
timeFrame: At 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Baptist Medical Center Princeton
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: University of California - Davis Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: West Palm Beach
country: United States
facility: JFK Medical Center
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Kansas City
country: United States
facility: Via Christi Regional Medical Center - St. Francis Campus
state: Kansas
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Morristown
country: United States
facility: Atlantic Health System - Morristown Memorial Hospital
state: New Jersey
city: New York
country: United States
facility: New York-Presbyterian/Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: New York University Hospital
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: München
country: Germany
facility: München Grosshadern
state: Bavaria
city: Mainz
country: Germany
facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz
state: Rhinela
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
state: Saxony
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bernau
country: Germany
facility: Immanuelklinikum Bernau und Herzzentrum Brandenburg
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital
city: Düsseldorf
country: Germany
facility: Medizinische Einrichtungen der Universität Düsseldorf
city: Gießen
country: Germany
facility: Klinikum der Justus-Liebig-Universität
city: Göttingen
country: Germany
facility: Universitatsmedizin Gottingen Georg-August-Universitat
city: Hamburg
country: Germany
facility: Katholisches Marienkrankenhaus GmbH
city: Heidelberg
country: Germany
facility: Klinikum der Ruprecht-Karls-Universität Heidelberg
city: Karlsburg
country: Germany
facility: Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG.
city: Köln
country: Germany
facility: Medizinische Einrichtungen der Universitat zu Koln
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universität Magdeburg
city: München
country: Germany
facility: Klinikum Rechts Der Isar der Technischen Universitat Munchen
city: Osnabrück
country: Germany
facility: Niels-Stensen-Kliniken Marienhospital Osnabrück
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Jerusalem
country: Israel
facility: Hadassah - Ein Kerem
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Milano
country: Italy
facility: Ospedale San Raffaele- Cardiac
state: Lombard
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombard
city: Milano
country: Italy
facility: Policlinico San Donato
state: Lombard
city: Catania
country: Italy
facility: Presidio Ospedaliero Ferrarotto Alessi
state: Sicilia
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro - Hospital Universitario
city: Málaga
country: Spain
facility: HCU Virgen de la Victoria
city: Aarau
country: Switzerland
facility: Kantonsspital
city: Bern
country: Switzerland
facility: Inselspital - University Hospital of Bern
city: Zürich
country: Switzerland
facility: Universitaets Spital Zuerich
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Cedars Sinai, Los Angeles CA
name: Dr. Saibal Kar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Zürich
name: Prof. Francesco Maisano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sodhi 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.