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OpenTrials
Completed

NCT Number: NCT00402246

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

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.

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Atrial Fibrillation Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

In-Office Care

Other

Routine in-office care

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

    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 outcomes

  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.

Other outcomes

  1. Length of Hospital Stay (LOS)

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

    LOS per cardiovascular hospitalization

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Symbios Clinical

Registry information

Acronym: CONNECT

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 22, 2006
Registry last updated
Feb 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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