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

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ClinicalTrials.gov Identifier: NCT00402246
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : February 16, 2011
Last Update Posted : February 25, 2011
Sponsor:
Collaborator:
Symbios Clinical
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date  ICMJE November 17, 2006
First Posted Date  ICMJE November 22, 2006
Results First Submitted Date  ICMJE September 29, 2010
Results First Posted Date  ICMJE February 16, 2011
Last Update Posted Date February 25, 2011
Study Start Date  ICMJE November 2006
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2011)
Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues [ Time Frame: Enrollment to last visit (up to 15 month post-implant) ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2006)
To demonstrate that the remote management system reduces the time to clinical decision for arrhythmias, cardiovascular disease progression, and system issues compared to subjects receiving only in-office care.
Change History Complete list of historical versions of study NCT00402246 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
  • Health Care Utilization (HCU) [ Time Frame: Enrollment to last visit (up to 15 month post-implant) ]
    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)
  • Health Care Utilization: TEEs [ Time Frame: Enrollment to last visit (up to 15 months post-implant) ]
    Count of Transesophageal echocardiograms (TEEs) performed
  • Actions Taken for HCU Visits [ Time Frame: Enrollment to last visit (up to 15 month post-implant) ]
    Count of HCU visits that involved specific actions taken
  • Clinically Meaningful Alerts [ Time Frame: Enrollment to last visit (up to 15 month post-implant) ]
    Count of clinically meaningful alerts as classified by the clinician
  • Symptomatic AT/AF Alerts [ Time Frame: Enrollment to last visit (up to 15 month post-implant) ]
    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
  • AT/AF Alert Treatment [ Time Frame: Enrollment to last visit (up to 15 month post-implant) ]
    Count of the treatment (i.e. hospitalization, ED visit, unscheduled clinic office/urgent care visits) in response to the AT/AF alerts
  • Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations [ Time Frame: Enrollment to last visit (up to 15 month post-implant) ]
    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.
  • Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations [ Time Frame: From event onset to clinical decision ]
    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.
  • CareLink Transmission Compliance [ Time Frame: 3, 6, 9, 12 months visits ]
    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.
  • Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM) [ Time Frame: 1, 3, 6, 9, 12, and 15 months visits ]
    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.
  • State-Anxiety Scale [ Time Frame: 1, 3, 6, 9, 12, and 15 month visit ]
    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).
  • Trait-Anxiety Scale [ Time Frame: 1, 3, 6, 9, 12, and 15 months visits ]
    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).
  • Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG). [ Time Frame: After study enrollment has been completed; on average 15.8 months after the center had enrolled its first subject ]
    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
  • In-office Follow-up Burden: Distance Traveled [ Time Frame: 1 month visit ]
    Subjects' responses to the survey. Subjects were asked to provide the distance (in miles) from their home to the clinic/hospital.
  • In-office Follow-up Burden: Patient Expenses [ Time Frame: 1 month ]
    On a survey at the one month visit, the patient estimated their expenses in traveling to that visit.
  • In-office Follow-up Burden: Hours Absent From Work Due to Visit [ Time Frame: 1 month ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2006)
To evaluate the impact of remote management on healthcare utilization (hospitalizations, ER visits, office visits)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision
Official Title  ICMJE CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Arrhythmia
  • Tachycardia
  • Atrial Fibrillation
  • Ventricular Fibrillation
Intervention  ICMJE
  • 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.

  • Other: In-Office Care
    Routine in-office care
Study Arms  ICMJE
  • Experimental: Remote Arm
    Remote Management
    Intervention: Other: Remote Management
  • Active Comparator: In-office Arm
    In-Office Care
    Intervention: Other: In-Office Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2009)
2009
Original Enrollment  ICMJE
 (submitted: November 17, 2006)
2000
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00402246
Other Study ID Numbers  ICMJE 605
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CONNECT Trial Leader, Medtronic, Inc.
Study Sponsor  ICMJE Medtronic Cardiac Rhythm and Heart Failure
Collaborators  ICMJE Symbios Clinical
Investigators  ICMJE
Principal Investigator: George Crossley, M.D. Mid-State Cardiology
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP