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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

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.

Condition or disease Intervention/treatment Phase
Arrhythmia Tachycardia Atrial Fibrillation Ventricular Fibrillation Other: Remote Management Other: In-Office Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2009 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision
Study Start Date : November 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009


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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. Health Care Utilization: TEEs [ Time Frame: Enrollment to last visit (up to 15 months post-implant) ]
    Count of Transesophageal echocardiograms (TEEs) performed

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.


  11. 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).

  12. 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).

  13. 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

  14. 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.

  15. 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.

  16. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402246


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Locations
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Mobile, Alabama, United States
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Mesa, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
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Fort Smith, Arkansas, United States
Little Rock, Arkansas, United States
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Madison, Wisconsin, United States
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Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Symbios Clinical
Investigators
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Principal Investigator: George Crossley, M.D. Mid-State Cardiology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CONNECT Trial Leader, Medtronic, Inc.
ClinicalTrials.gov Identifier: NCT00402246     History of Changes
Other Study ID Numbers: 605
First Posted: November 22, 2006    Key Record Dates
Results First Posted: February 16, 2011
Last Update Posted: February 25, 2011
Last Verified: February 2011
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Randomized Controlled Trials
Defibrillators
Remote Consultation
Additional relevant MeSH terms:
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Atrial Fibrillation
Tachycardia
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease