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
PHASE4
1682 participants
INTERVENTIONAL
2009-03-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Monthly Review Arm
Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
Monthly Review Arm
Monthly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
Quarterly Review Arm
Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
Quarterly Review Arm
Quarterly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
Interventions
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Monthly Review Arm
Monthly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
Quarterly Review Arm
Quarterly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
Eligibility Criteria
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Inclusion Criteria
* Subject is at least 18 years of age
* Subject is willing and able to comply with Clinical Investigation Plan
* Subject is willing and able to transmit data using Medtronic CareLink® Network
* Subject has market released right atrial (RA) (if applicable), right ventricular (RV), and left ventricular (LV) (if applicable) leads and one of the following generators implanted: Concerto® CRT-D - Model C154DWK, Virtuoso® DR ICD - Model D154AWG, Virtuoso® VR ICD - Model D154VWC, Consulta™ CRT-D - Model D224TRK, Secura™ DR ICD - Model D224DRG, Secura™ VR ICD - Model D224VRC, or any future market released Medtronic generator with wireless telemetry, Cardiac Compass with OptiVol Fluid Status Monitoring, and that is supported by the Medtronic CareLink Network
Exclusion Criteria
* Subject has life expectancy of less than 1 year
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Wilson Tang, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiovascular Medicine, Cleveland Clinic
Locations
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Birmingham, Alabama, United States
Mobile, Alabama, United States
Anchorage, Alaska, United States
Mesa, Arizona, United States
Fort Smith, Arkansas, United States
Little Rock, Arkansas, United States
Alhambra, California, United States
Berkeley, California, United States
Burbank, California, United States
Chula Vista, California, United States
La Jolla, California, United States
Larkspur, California, United States
Pomona, California, United States
Rancho Mirage, California, United States
Riverside, California, United States
San Francisco, California, United States
Torrance, California, United States
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Brandenton, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Fort Lauderdale, Florida, United States
Gainesville, Florida, United States
Inverness, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Trinity, Florida, United States
Augusta, Georgia, United States
Columbus, Georgia, United States
Chicago, Illinois, United States
Kankakee, Illinois, United States
Oak Lawn, Illinois, United States
Rockford, Illinois, United States
Bloomington, Indiana, United States
Muncie, Indiana, United States
Munster, Indiana, United States
Terre Haute, Indiana, United States
Davenport, Iowa, United States
Des Moines, Iowa, United States
Ashland, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Shreveport, Louisiana, United States
Bangor, Maine, United States
Glen Burnie, Maryland, United States
Rockville, Maryland, United States
Salisbury, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Grand Blanc, Michigan, United States
Grand Rapids, Michigan, United States
Petosky, Michigan, United States
Sterling Heights, Michigan, United States
Coon Rapids, Minnesota, United States
Minneapolis, Minnesota, United States
Saint Cloud, Minnesota, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
Saint Joseph, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Reno, Nevada, United States
Bridgewater, New Jersey, United States
Galloway, New Jersey, United States
Newark, New Jersey, United States
Ocean City, New Jersey, United States
Voorhees Township, New Jersey, United States
Buffalo, New York, United States
Fayetteville, New York, United States
Garden City, New York, United States
Durham, North Carolina, United States
Gastonia, North Carolina, United States
Greensboro, North Carolina, United States
Wilmington, North Carolina, United States
Minot, North Dakota, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Kettering, Ohio, United States
Poland, Ohio, United States
Steubenville, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Bend, Oregon, United States
Doylestown, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
Columbia, South Carolina, United States
Greenwood, South Carolina, United States
Spartanburg, South Carolina, United States
West Columbia, South Carolina, United States
Germantown, Tennessee, United States
Johnson City, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Lynchburg, Virginia, United States
Spokane, Washington, United States
Madison, Wisconsin, United States
Countries
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Other Identifiers
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OptiVol® Care Pathway
Identifier Type: -
Identifier Source: org_study_id
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