CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision

NCT00402246 | Completed Results

• 1 other identifier: 605
• Study Type: interventional
• Target: 2,009
• Locations: 1 country
• Sites: 127

Brief Summary

The purpose of this study is to determine whether the ability of clinicians to receive and review information from patients implanted with a heart device over the internet (remote care) is comparable to patients who are seen in-office for routine visits to check the status of their device.

Conditions

Arrhythmia; Tachycardia; Atrial Fibrillation; Ventricular Fibrillation

Keywords

Randomized Controlled Trials; Defibrillators; Remote Consultation

Outcome Measures

Primary Outcomes (1)

• Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues

  Days from device detection of a clinical event to a decision being made in response to the event, as reported by the clinician or as evidenced by device data obtained at interrogation. A clinical event could be any of the following that satisfied pre-specified thresholds: arrhythmias (e.g. at least 12 hours of atrial tachycard/atrial fibrillation in a day), cardiovascular disease progression (e.g. multiple device shocks delivered to terminate a single episode), or device issues (e.g. low battery).

  Enrollment to last visit (up to 15 month post-implant)

Secondary Outcomes (16)

• Health Care Utilization (HCU)

  Enrollment to last visit (up to 15 month post-implant)

• Health Care Utilization: TEEs

  Enrollment to last visit (up to 15 months post-implant)

• Actions Taken for HCU Visits

  Enrollment to last visit (up to 15 month post-implant)

• Clinically Meaningful Alerts

  Enrollment to last visit (up to 15 month post-implant)

• Symptomatic AT/AF Alerts

  Enrollment to last visit (up to 15 month post-implant)

Other Outcomes (1)

• Length of Hospital Stay (LOS)

  Enrollment to last visit (up to 15 month post-implant)

Study Arms (2)

Remote Arm

EXPERIMENTAL

Remote Management

Other: Remote Management

In-office Arm

ACTIVE COMPARATOR

In-Office Care

Other: In-Office Care

Interventions

Remote Management OTHER

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.

Remote Arm

In-Office Care OTHER

Routine in-office care

In-office Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient will be implanted with a Medtronic Conexus-enabled Cardiac Resynchronization Therapy Defibrillator (CRT-D) or Implantable Cardioverter-Defibrillator (DR-ICD) device.

You may not qualify if:

• Patient has permanent rapid beats in the upper chamber of the heart (Atrial Fibrillation) - (constant atrial fibrillation in which pharmacological therapy or cardioversion failed or not attempted).
• 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).

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Symbios Clinical: collaborator

Study Sites (127)

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Mobile, Alabama, United States

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Mesa, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Fort Smith, Arkansas, United States

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Little Rock, Arkansas, United States

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East Palo Alto, California, United States

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Inglewood, California, United States

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Los Angeles, California, United States

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Napa, California, United States

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Rancho Mirage, California, United States

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San Bernardino, California, United States

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San Diego, California, United States

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Santa Rosa, California, United States

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Colorado Springs, Colorado, United States

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Bridgeport, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Brooksville, Florida, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Lakeland, Florida, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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Safety Harbor, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Vero Beach, Florida, United States

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Atlanta, Georgia, United States

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Gainesville, Georgia, United States

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Aurora, Illinois, United States

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Chicago, Illinois, United States

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Kankakee, Illinois, United States

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Moline, Illinois, United States

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Rockford, Illinois, United States

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Springfield, Illinois, United States

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Bloomington, Indiana, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Ames, Iowa, United States

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Kansas City, Kansas, United States

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Overland Park, Kansas, United States

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Ashland, Kentucky, United States

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Louisville, Kentucky, United States

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Owensboro, Kentucky, United States

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Covington, Louisiana, United States

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Baltimore, Maryland, United States

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Glen Burnie, Maryland, United States

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Lanham, Maryland, United States

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Randallstown, Maryland, United States

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Salisbury, Maryland, United States

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Takoma Park, Maryland, United States

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Boston, Massachusetts, United States

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Chelmsford, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Grand Blanc, Michigan, United States

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Petoskey, Michigan, United States

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Saginaw, Michigan, United States

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Saint Joseph, Michigan, United States

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Ypsilanti, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint Cloud, Minnesota, United States

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Saint Paul, Minnesota, United States

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Hattiesburg, Mississippi, United States

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Columbia, Missouri, United States

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Mexico, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Kearney, Nebraska, United States

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Omaha, Nebraska, United States

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Manchester, New Hampshire, United States

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Cherry Hill, New Jersey, United States

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Newark, New Jersey, United States

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Ridgewood, New Jersey, United States

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Wayne, New Jersey, United States

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West Orange, New Jersey, United States

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Flushing, New York, United States

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Mineola, New York, United States

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New York, New York, United States

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Poughkeepsie, New York, United States

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Rochester, New York, United States

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Williamsville, New York, United States

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Gastonia, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Fairview Park, Ohio, United States

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Kettering, Ohio, United States

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Mayfield Heights, Ohio, United States

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Whitehall, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Abington, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Langhorne, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Wormleysburg, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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York, Pennsylvania, United States

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Columbia, South Carolina, United States

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Florence, South Carolina, United States

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Greenwood, South Carolina, United States

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Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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The Woodlands, Texas, United States

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Fairfax, Virginia, United States

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Fredericksburg, Virginia, United States

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Lynchburg, Virginia, United States

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Portsmouth, Virginia, United States

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Morgantown, West Virginia, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Related Publications (2)

• 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.

  PMID: 21255955 DERIVED

• 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.

  PMID: 19061696 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Tachycardia; Atrial Fibrillation; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease

Results Point of Contact

• Title: CONNECT Clinical Trial Specialist
• Organization: Medtronic, Inc

medtronicCRMtrials@medtronic.com

Study Officials

• George Crossley, M.D.

  Mid-State Cardiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 22, 2006
• Study Start: November 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 25, 2011
• Results First Posted: February 16, 2011

Record last verified: 2011-02

Locations

US (127)