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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03502811
Recruitment Status : Completed
First Posted : April 19, 2018
Results First Posted : February 16, 2022
Last Update Posted : February 16, 2022
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Mitral Valve Regurgitation Mitral Regurgitation Device: MitraClip NTR/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.

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Study Type : Observational
Actual Enrollment : 1041 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip® Devices (EXPAND)
Actual Study Start Date : April 26, 2018
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : December 31, 2020

Group/Cohort Intervention/treatment
MitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR and XTR system
Device: MitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR/XTR system.




Primary Outcome Measures :
  1. 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).

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502811


Locations
Show Show 57 study locations
Sponsors and Collaborators
Abbott Medical Devices
Abbott
Investigators
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Principal Investigator: Dr. Saibal Kar, MD Cedars Sinai, Los Angeles CA
Principal Investigator: Prof. Francesco Maisano, MD University Hospital, Zürich
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Study Protocol  [PDF] June 26, 2018
Statistical Analysis Plan  [PDF] July 9, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03502811    
Other Study ID Numbers: 17-518
First Posted: April 19, 2018    Key Record Dates
Results First Posted: February 16, 2022
Last Update Posted: February 16, 2022
Last Verified: December 2021
Keywords provided by Abbott Medical Devices:
MitraClip
MitraClip NTR
MitraClip XTR
Mitral Regurgitation
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases