Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
156 participants
INTERVENTIONAL
2003-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
DOUBLE
Interventions
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Fluid Status Monitoring (OptiVol™)
Thoracic Fluid Status Software downloaded on all subjects enrolled in the trial
Eligibility Criteria
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Inclusion Criteria
* Subjects with an ICD placed in the upper part of the left or right side of their chest.
* Subjects with a lead (flexible wire that sends electrical signals from the ICD directly to the heart tissue) that is inserted through a vein and placed in the right ventricle (RV) of the heart (a transvenous RV lead).
* Subjects who underwent the ICD implant procedure, or any readjusting of the ICD, 30 days or more prior to enrolling in the study.
Exclusion Criteria
* Subjects who have received a heart transplant.
* Subjects who are unable or unwilling to follow the study schedule of visits.
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Medtronic CRDM
Locations
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Alaska Cardiovascular Research Foundation
Anchorage, Alaska, United States
Palm Beach Heart Institute
Atlantis, Florida, United States
Fort Wayne Cardiology
Fort Wayne, Indiana, United States
Genesis Medical Center
Davenport, Iowa, United States
Michigan Cardiovascular Institute
Saginaw, Michigan, United States
North Shore University Hospital
Manhasset, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic Foundation Department of Hear Failure/Transplantation
Cleveland, Ohio, United States
The Ohio State University Hospital
Columbus, Ohio, United States
The Pavillion at Doylestown Hospital
Doylestown, Pennsylvania, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
Intermountain Medical Center
Salt Lake City, Utah, United States
University of Calgary/Foothills Hospital
Calgary, Alberta, Canada
Kingston General Hospital
Kingston, Ontario, Canada
Queen Mary Hospital
Pok Fu Lam, Hong Kong, China
Prince of Wales Hospital/The Chinese University of Hong Kong
Shatin, Hong Kong, China
Countries
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Other Identifiers
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228
Identifier Type: -
Identifier Source: org_study_id