CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision
NCT ID: NCT00402246
Last Updated: 2011-02-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2009 participants
INTERVENTIONAL
2006-11-30
2009-09-30
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
DIAGNOSTIC
NONE
Study Groups
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Remote Arm
Remote Management
Remote Management
The Remote Management method of treating patients consists of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action.
In-office Arm
In-Office Care
In-Office Care
Routine in-office care
Interventions
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Remote Management
The Remote Management method of treating patients consists of 3 components:
CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)
Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line
CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.
The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action.
In-Office Care
Routine in-office care
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient plans to be on chronic warfarin therapy post-implant and is no longer receiving therapies to attempt to control the rhythm of the beats in their atrium.
* Patient has a previous ICD, CRT-D, Implantable Pulse Generator (IPG) or Cardiac Resynchronization Therapy Pacemaker (CRT-P).
18 Years
ALL
No
Sponsors
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Symbios Clinical
OTHER
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Medtronic, Inc.
Principal Investigators
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George Crossley, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mid-State Cardiology
Locations
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Mobile, Alabama, United States
Mesa, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Fort Smith, Arkansas, United States
Little Rock, Arkansas, United States
East Palo Alto, California, United States
Inglewood, California, United States
Los Angeles, California, United States
Napa, California, United States
Rancho Mirage, California, United States
San Bernardino, California, United States
San Diego, California, United States
Santa Rosa, California, United States
Colorado Springs, Colorado, United States
Bridgeport, Connecticut, United States
Washington D.C., District of Columbia, United States
Brooksville, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Lakeland, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Safety Harbor, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
Atlanta, Georgia, United States
Gainesville, Georgia, United States
Aurora, Illinois, United States
Chicago, Illinois, United States
Kankakee, Illinois, United States
Moline, Illinois, United States
Rockford, Illinois, United States
Springfield, Illinois, United States
Bloomington, Indiana, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Ames, Iowa, United States
Kansas City, Kansas, United States
Overland Park, Kansas, United States
Ashland, Kentucky, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
Covington, Louisiana, United States
Baltimore, Maryland, United States
Glen Burnie, Maryland, United States
Lanham, Maryland, United States
Randallstown, Maryland, United States
Salisbury, Maryland, United States
Takoma Park, Maryland, United States
Boston, Massachusetts, United States
Chelmsford, Massachusetts, United States
Ann Arbor, Michigan, United States
Grand Blanc, Michigan, United States
Petoskey, Michigan, United States
Saginaw, Michigan, United States
Saint Joseph, Michigan, United States
Ypsilanti, Michigan, United States
Minneapolis, Minnesota, United States
Saint Cloud, Minnesota, United States
Saint Paul, Minnesota, United States
Hattiesburg, Mississippi, United States
Columbia, Missouri, United States
Mexico, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Kearney, Nebraska, United States
Omaha, Nebraska, United States
Manchester, New Hampshire, United States
Cherry Hill, New Jersey, United States
Newark, New Jersey, United States
Ridgewood, New Jersey, United States
Wayne, New Jersey, United States
West Orange, New Jersey, United States
Flushing, New York, United States
Mineola, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Rochester, New York, United States
Williamsville, New York, United States
Gastonia, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Bismarck, North Dakota, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Fairview Park, Ohio, United States
Kettering, Ohio, United States
Mayfield Heights, Ohio, United States
Whitehall, Ohio, United States
Oklahoma City, Oklahoma, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Abington, Pennsylvania, United States
Doylestown, Pennsylvania, United States
Erie, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Langhorne, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wormleysburg, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
York, Pennsylvania, United States
Columbia, South Carolina, United States
Florence, South Carolina, United States
Greenwood, South Carolina, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
Fairfax, Virginia, United States
Fredericksburg, Virginia, United States
Lynchburg, Virginia, United States
Portsmouth, Virginia, United States
Morgantown, West Virginia, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Countries
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References
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Crossley GH, Boyle A, Vitense H, Chang Y, Mead RH; CONNECT Investigators. The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. J Am Coll Cardiol. 2011 Mar 8;57(10):1181-9. doi: 10.1016/j.jacc.2010.12.012. Epub 2011 Jan 20.
Crossley G, Boyle A, Vitense H, Sherfesee L, Mead RH. Trial design of the clinical evaluation of remote notification to reduce time to clinical decision: the Clinical evaluation Of remote NotificatioN to rEduCe Time to clinical decision (CONNECT) study. Am Heart J. 2008 Nov;156(5):840-6. doi: 10.1016/j.ahj.2008.06.028. Epub 2008 Sep 11.
Other Identifiers
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605
Identifier Type: -
Identifier Source: org_study_id
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