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

This study has been completed.
Sponsor:
Collaborator:
Symbios Clinical
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00402246
First received: November 17, 2006
Last updated: February 23, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention
Arrhythmia
Tachycardia
Atrial Fibrillation
Ventricular Fibrillation
 Other: Remote Management
Other: In-Office Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • Health Care Utilization (HCU) [ Time Frame: Enrollment to last visit (up to 15 month post-implant) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Count of Transesophageal echocardiograms (TEEs) performed

  • Actions Taken for HCU Visits [ Time Frame: Enrollment to last visit (up to 15 month post-implant) ] [ Designated as safety issue: No ]
    Count of HCU visits that involved specific actions taken

  • Clinically Meaningful Alerts [ Time Frame: Enrollment to last visit (up to 15 month post-implant) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 2009
Study Start Date: November 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402246

  Show 127 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Symbios Clinical
Investigators
Principal Investigator: George Crossley, M.D. Mid-State Cardiology
  More Information

No publications provided by Medtronic Cardiac Rhythm Disease Management

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: CONNECT Trial Leader, Medtronic, Inc.
ClinicalTrials.gov Identifier: NCT00402246     History of Changes
Other Study ID Numbers: 605
Study First Received: November 17, 2006
Results First Received: September 29, 2010
Last Updated: February 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Randomized Controlled Trials
Defibrillators
Remote Consultation

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Tachycardia
Ventricular Fibrillation
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013