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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Arrhythmia; Ventricular Fibrillation; Tachycardia
• Intervention / Treatment: Other: Remote Management; Other: In-Office Care

• Study Type: Interventional
• Enrollment (Actual): 2009
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States
  • Arizona
    • Mesa, Arizona, United States
    • Scottsdale, Arizona, United States
    • Tucson, Arizona, United States
  • Arkansas
    • Fort Smith, Arkansas, United States
    • Little Rock, Arkansas, United States
  • California
    • 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
    • Colorado Springs, Colorado, United States
  • Connecticut
    • Bridgeport, Connecticut, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • 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
  • Georgia
    • Atlanta, Georgia, United States
    • Gainesville, Georgia, United States
  • Illinois
    • Aurora, Illinois, United States
    • Chicago, Illinois, United States
    • Kankakee, Illinois, United States
    • Moline, Illinois, United States
    • Rockford, Illinois, United States
    • Springfield, Illinois, United States
  • Indiana
    • Bloomington, Indiana, United States
    • Evansville, Indiana, United States
    • Indianapolis, Indiana, United States
  • Iowa
    • Ames, Iowa, United States
  • Kansas
    • Kansas City, Kansas, United States
    • Overland Park, Kansas, United States
  • Kentucky
    • Ashland, Kentucky, United States
    • Louisville, Kentucky, United States
    • Owensboro, Kentucky, United States
  • Louisiana
    • Covington, Louisiana, United States
  • Maryland
    • 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
  • Massachusetts
    • Boston, Massachusetts, United States
    • Chelmsford, Massachusetts, United States
  • Michigan
    • 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
  • Minnesota
    • Minneapolis, Minnesota, United States
    • Saint Paul, Minnesota, United States
    • St. Cloud, Minnesota, United States
  • Mississippi
    • Hattiesburg, Mississippi, United States
  • Missouri
    • Columbia, Missouri, United States
    • Mexico, Missouri, United States
    • Saint Louis, Missouri, United States
    • Springfield, Missouri, United States
  • Nebraska
    • Kearney, Nebraska, United States
    • Omaha, Nebraska, United States
  • New Hampshire
    • Manchester, New Hampshire, United States
  • New Jersey
    • 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
  • New York
    • 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
  • North Carolina
    • Gastonia, North Carolina, United States
    • Raleigh, North Carolina, United States
    • Winston Salem, North Carolina, United States
  • North Dakota
    • Bismarck, North Dakota, United States
  • Ohio
    • 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
    • Oklahoma City, Oklahoma, United States
  • Oregon
    • Eugene, Oregon, United States
    • Portland, Oregon, United States
  • Pennsylvania
    • 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
  • South Carolina
    • Columbia, South Carolina, United States
    • Florence, South Carolina, United States
    • Greenwood, South Carolina, United States
  • Tennessee
    • Chattanooga, Tennessee, United States
    • Germantown, Tennessee, United States
    • Knoxville, Tennessee, United States
    • Nashville, Tennessee, United States
  • Texas
    • Amarillo, Texas, United States
    • Corpus Christi, Texas, United States
    • Dallas, Texas, United States
    • Houston, Texas, United States
    • San Antonio, Texas, United States
    • Woodlands, Texas, United States
  • Virginia
    • Fairfax, Virginia, United States
    • Fredericksburg, Virginia, United States
    • Lynchburg, Virginia, United States
    • Portsmouth, Virginia, United States
  • West Virginia
    • Morgantown, West Virginia, United States
  • Wisconsin
    • Madison, Wisconsin, United States
    • Milwaukee, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Arm; Remote Management	Other: 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.
Active Comparator: In-office Arm; In-Office Care	Other: In-Office Care; Routine in-office care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Care Utilization (HCU)	Count of HCU visits for each HCU type (cardiovascular (CV) hospitalizations, cardiovascular (CV) emergency department (ED), and cardiovascular (CV) unscheduled clinic office/urgent care visits)	Enrollment to last visit (up to 15 month post-implant)
Health Care Utilization: TEEs	Count of Transesophageal echocardiograms (TEEs) performed	Enrollment to last visit (up to 15 months post-implant)
Actions Taken for HCU Visits	Count of HCU visits that involved specific actions taken	Enrollment to last visit (up to 15 month post-implant)
Clinically Meaningful Alerts	Count of clinically meaningful alerts as classified by the clinician	Enrollment to last visit (up to 15 month post-implant)
Symptomatic AT/AF Alerts	AT/AF represents atrial tachycardia or atrial fibrillation which are arrhythmias involving rapid beating of the atrial chambers of the heart. The devices in this study store how many hours each day that a patient experiences AT/AF. The patient may not be aware they are experiencing these atrial arrhythmias, but if the AT/AF is accompanied by symptoms, the AT/AF is said to be symptomatic AT/AF. Devices in this study have an alert that fires if the patient experiences at least a programmed amount of AT/AF in a day. Measure is count of symptomatic AT/AF alerts as classified by the clinician	Enrollment to last visit (up to 15 month post-implant)
AT/AF Alert Treatment	Count of the treatment (i.e. hospitalization, ED visit, unscheduled clinic office/urgent care visits) in response to the AT/AF alerts	Enrollment to last visit (up to 15 month post-implant)
Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations	Days from a symptom-driven device interrogation event onset to a clinical decision being made in response to the event as reported by the clinician. An event is defined as a subject complaint received by the managing clinician in which the clinician determines that he/she must interrogate the subject's device to properly treat the subject.	Enrollment to last visit (up to 15 month post-implant)
Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations	Days from device detection of a clinical event or a symptom-driven device interrogation event onset to a clinical decision, as reported by the clinician or as evidenced by device data obtained at interrogation. A clinical event is an event as defined in the primary objective. A symptom-driven device interrogation event is defined as a subject complaint received by the managing clinician in which the clinician determines that he/she must interrogate the subject's device to properly treat the subject.	From event onset to clinical decision
CareLink Transmission Compliance	The CareLink Transmission Compliance Rate for a particular visit (e.g. 3 month visit) is the proportion (ranging from 0 to 1) of subjects with device interrogation data remotely transmitted via the CareLink system on the date it was scheduled to be sent for that visit. The proportion is a fraction in which the denominator is the number of subjects in the Remote Arm who were not exited from the trial prior to the visit of interest, and the numberator is the number of Remote Arm subjects who successfully transmitted device data via the CareLink system on the date it was scheduled to be sent.	3, 6, 9, 12 months visits
Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)	LV Capture Threshold is the required energy(volts) necessary to cause the left ventricule to contract. It is important that a device which paces the left ventricule be set to a threshold such that current conducted through the left ventricular lead will induce contraction in the left ventricle. However, these thresholds may vary over time. The standard deviation and range (maximum LVCM threshold - minimum LVCM threshold) of the most recent 14 days of LVCM results prior to each follow-up visit were determined for each subject and used to assess within-patient variability in LV thresholds.	1, 3, 6, 9, 12, and 15 months visits
State-Anxiety Scale	The State-Anxiety scales for each subject were obtained at multiple time points. The State-Anxiety scale was derived by summing the 20 scores in the State section of the State-Trait Anxiety Inventory (STAI) questionnaire. The State-Anxiety scales can vary from a minimum of 20 (best possible) to a maximum of 80 (worst possible).	1, 3, 6, 9, 12, and 15 month visit
Trait-Anxiety Scale	The Trait-Anxiety scales for each subject were obtained at multiple time points. The Trait-Anxiety scale was derived by summing the 20 scores in the Trait section of the STAI questionnaire. The Trait-Anxiety scales can vary from a minimum of 20 (best possible) to a maximum of 80 (worst possible).	1, 3, 6, 9, 12, and 15 months visits
Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).	Following the completion of enrollment in the study, participating clinicians were asked to complete a survey assessing their overall satisfaction with the wireless telemetry feature. Clinicians' rating (1=strongly disagree, 5=strongly agree) of the overall satisfaction with the wireless telemetry feature of the device	After study enrollment has been completed; on average 15.8 months after the center had enrolled its first subject
In-office Follow-up Burden: Distance Traveled	Subjects' responses to the survey. Subjects were asked to provide the distance (in miles) from their home to the clinic/hospital.	1 month visit
In-office Follow-up Burden: Patient Expenses	On a survey at the one month visit, the patient estimated their expenses in traveling to that visit.	1 month
In-office Follow-up Burden: Hours Absent From Work Due to Visit	Subjects were asked at their one month visit to indicate on a survey how many hours of work they were missing to attend that visit.	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay (LOS)	LOS per cardiovascular hospitalization	Enrollment to last visit (up to 15 month post-implant)

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Collaborators: Symbios Clinical
• Investigators: Principal Investigator: George Crossley, M.D., Mid-State Cardiology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: November 17, 2006
• First Submitted That Met QC Criteria: November 17, 2006
• First Posted (Estimate): November 22, 2006

Study Record Updates

• Last Update Posted (Estimate): February 25, 2011
• Last Update Submitted That Met QC Criteria: February 23, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Remote Consultation; Randomized Controlled Trials; Defibrillators
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Atrial Fibrillation; Ventricular Fibrillation; Tachycardia
• Other Study ID Numbers: 605