Mitral Valve RegurgitationNCT03502811
The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices
An observational study of Mitral Valve Regurgitation and Mitral Regurgitation, run by Abbott Medical Devices at 57 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation, Mitral Regurgitation
- What is being tested?
- MitraClip NTR/XTR System
- Type of treatment
- Medical device
- How many people
- 1,041 participants
- Where
- 57 sitesin 8 countries
- Study dates
- 26 Apr 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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+)
Who cannot join
- 1. Subjects participating in another clinical study that may impact the follow-up or results of this study
Trial locations and contacts
57 sites in 8 countries.
57 sites in 8 countries
United States22 sites
University of Colorado Hospital
Aurora, Colorado, 80309
Baptist Medical Center Princeton
Birmingham, Alabama, 35211
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Virginia Medical Center
Charlottesville, Virginia, 22903
Northwestern Memorial Hospital
Chicago, Illinois, 60007
Christ Hospital
Cincinnati, Ohio, 41073
Via Christi Regional Medical Center - St. Francis Campus
Kansas City, Kansas, 67218
St. Luke's Hospital
Kansas City, Missouri, 64102
Scripps Health
La Jolla, California, 92037
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Atlantic Health System - Morristown Memorial Hospital
Morristown, New Jersey, 07960
Intermountain Medical Center
Murray, Utah, 84107
St. Thomas Hospital
Nashville, Tennessee, 37236
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10001
Mount Sinai Hospital
New York, New York, 10011
New York University Hospital
New York, New York, 10016
Sentara Norfolk General Hospital
Norfolk, Virginia, 23504
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85001
University of California - Davis Medical Center
Sacramento, California, 95817
University of Washington Medical Center
Seattle, Washington, 98101
JFK Medical Center
West Palm Beach, Florida, 33401
Germany18 sites
Kerckhoff-Klinik gGmbH
Bad Nauheim
Deutsches Herzzentrum Berlin
Berlin
Immanuelklinikum Bernau und Herzzentrum Brandenburg
Bernau
Medizinische Einrichtungen der Universitat zu Koln
Cologne
St.-Johannes-Hospital
Dortmund
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf
Klinikum der Justus-Liebig-Universität
Giessen
Universitatsmedizin Gottingen Georg-August-Universitat
Göttingen
Katholisches Marienkrankenhaus GmbH
Hamburg, 22087
Klinikum der Ruprecht-Karls-Universität Heidelberg
Heidelberg
Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG.
Karlsburg
Herzzentrum Leipzig GmbH
Leipzig, Saxony, 04289
Otto-von-Guericke-Universität Magdeburg
Magdeburg
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz
Mainz, Rhinela, 55131
München Grosshadern
München, Bavaria, 81377
Klinikum Rechts Der Isar der Technischen Universitat Munchen
München
Niels-Stensen-Kliniken Marienhospital Osnabrück
Osnabrück
Universitatsklinikum Ulm
Ulm
Italy5 sites
Presidio Ospedaliero Ferrarotto Alessi
Catania, Sicily, 95124
Ospedale San Raffaele- Cardiac
Milan, Lombard, 20132
Ospedale San Raffaele
Milan, Lombard, 20132
Policlinico San Donato
Milan, Lombard, 20132
Centro Cardiologico Monzino
Milan
Netherlands3 sites
Catharina Ziekenhuis
Eindhoven
St. Antonius Ziekenhuis
Nieuwegein
UMC Utrecht
Utrecht
Spain3 sites
Hospital de la Santa Creu I Sant Pau
Barcelona
Hospital Puerta de Hierro - Hospital Universitario
Madrid
HCU Virgen de la Victoria
Málaga
Switzerland3 sites
Kantonsspital
Aarau
Inselspital - University Hospital of Bern
Bern, 3010
Universitaets Spital Zuerich
Zurich, 8091
Israel2 sites
Hadassah - Ein Kerem
Jerusalem
Shaare Zedek Medical Center
Jerusalem
About this study
Official title: 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.
Read the 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.
- Conditions
- Mitral Valve Regurgitation, Mitral Regurgitation
- Being tested
- MitraClip NTR/XTR System
- Keywords
- MitraClip, MitraClip NTR, MitraClip XTR, Mitral Regurgitation
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClip NTR/XTR SystemDevice
Percutaneous mitral valve repair using the MitraClip NTR/XTR system.
| Study group | Role | What they receive |
|---|---|---|
| MitraClip NTR/XTR System | Percutaneous mitral valve repair using the MitraClip NTR and XTR system Receives: Device: MitraClip NTR/XTR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: At 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start26 Apr 2018
- Primary completion5 Apr 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,041 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Dr. Saibal Kar, MD, Principal investigator, Cedars Sinai, Los Angeles CAProf. Francesco Maisano, MD, Principal investigator, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502811
- Sponsor's protocol ID
- 17-518
- Status last verified
- Dec 2021
- First submitted
- 11 Apr 2018
- Last updated
- 16 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 36922046Shuvy 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.
PubMed 36599332Sodhi 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.
PubMed 36075643
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip® Devices (EXPAND)
- ClinicalTrials.gov ID
- NCT03502811
- Acronym / sponsor ID
- 17-518
- Conditions
- Mitral Valve Regurgitation, Mitral Regurgitation
- Keywords
- MitraClip, MitraClip NTR, MitraClip XTR, Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,041 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Abbott
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Posted 16 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MitraClip NTR/XTR System | – | Device: MitraClip NTR/XTR SystemPercutaneous mitral valve repair using the MitraClip NTR and XTR system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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+)
Key exclusion criteria (1 listed)
- 1. Subjects participating in another clinical study that may impact the follow-up or results of this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitraClip NTR/XTR SystemPercutaneous mitral valve repair using the MitraClip NTR/XTR system. | Device | MitraClip NTR/XTR System |
Primary outcome
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).
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36922046Kar 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.
- Derived from this study: PubMed 36599332Shuvy 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.
- Derived from this study: PubMed 36075643Sodhi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Saibal Kar, MD principal investigator
Cedars Sinai, Los Angeles CA
Prof. Francesco Maisano, MD principal investigator
University Hospital, Zürich
57 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Regurgitation and Mitral Regurgitation, run by Abbott Medical Devices at 57 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Germany, Italy, Netherlands, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Measure: Number of Participants With Major Adverse Events (MAE) (time frame: At 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03502811, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.