Study Results
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View full resultsBasic Information
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COMPLETED
53 participants
OBSERVATIONAL
2018-06-28
2020-08-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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remedē System Subjects
Subjects who were implanted with the remedē System and actively followed as part of the remedē System Pivotal Trial at the time of study closure.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* In the investigator's opinion, willing and able to comply with all study requirements
* Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent (including Health Insurance Portability and Accountability Act \[HIPAA\] authorization in the US)
Exclusion Criteria
21 Years
ALL
No
Sponsors
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Respicardia, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robin Germany, MD
Role: STUDY_DIRECTOR
Respicardia, Inc.
Locations
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Keck Medical Center of USC
Los Angeles, California, United States
UF Health Jacksonville
Jacksonville, Florida, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States
University of Maryland, Baltimore
Baltimore, Maryland, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Washington University in St. Louis
St Louis, Missouri, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Cooper Health System
Cherry Hill, New Jersey, United States
Novant Clinical Research Institute Forsyth Medical Center
Winston-Salem, North Carolina, United States
The Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Wesley Neurology
Cordova, Tennessee, United States
Methodist Hospital
San Antonio, Texas, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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CR1079
Identifier Type: -
Identifier Source: org_study_id
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