A Feasibility Registry of Actigraphy Monitoring in Degenerative Mitral Regurgitation Subjects Receiving the MitraClip® Device



Status:Terminated
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/9/2018
Start Date:November 2016
End Date:December 2017

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A Feasibility Registry on Use of Actigraphy Monitoring in Degenerative Mitral Regurgitation (DMR) Subjects Receiving the MitraClip® Device

A prospective, open-label, and multi-centered feasibility registry.

This is a prospective, open-label, and multi-centered feasibility registry (single arm
study). Approximately 36 subjects with prohibitive risk degenerative mitral regurgitation
(DMR) who receive at least 1 commercial MitraClip will be registered at up to 10 US sites.

Inclusion Criteria:

- Subject must consent to receiving the MitraClip device

- Subject must consent, be able, and commit to wearing the Actiwatch continuously for
approximately 7 months

- Subject must consent to use of their data from this registry for purposes of
exploratory research and publication and presentation

Exclusion Criteria:

- Subject is not a member of vulnerable population

- Subject must not have any disabilities that preclude reliable data collection from the
Actiwatch, e.g., epilepsy with uncontrolled recurring episodes, serious stage
degenerative/disabling disease (e.g. Parkinson's disease), inability to walk or will
require walking aids, etc.
We found this trial at
8
sites
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: John Carroll, MD
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Phone: 704-355-4794
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Charlotte, NC
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Saibal Kar, MD
Phone: 310-423-3978
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Dr. Samir Kapadia, MD
Phone: 216-444-6735
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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8900 N Kendall Dr
Miami, Florida 33176
(786) 596-1960
Phone: 786-596-2959
Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
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Miami, FL
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Phoenix, Arizona 85006
Principal Investigator: Dr. Ashish Pershad, MD
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Richmond, Virginia 23226
Phone: 434-982-1058
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Richmond, VA
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200 1st Street Southwest
Rochester, Minnesota 55905
Phone: 507-284-3545
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Rochester, MN
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