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

Medtronic Cardiac Rhythm and Heart Failure2,009 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

2,009

Conditions

Arrhythmia Tachycardia Atrial Fibrillation Ventricular Fibrillation

Interventions

Remote ManagementOTHER

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 CareOTHER

Routine in-office care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (127)

Outcomes

Primary Outcomes

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).

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

Secondary Outcomes

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)

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

Health Care Utilization: TEEs

Count of Transesophageal echocardiograms (TEEs) performed

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

Actions Taken for HCU Visits

Count of HCU visits that involved specific actions taken

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

Clinically Meaningful Alerts

Count of clinically meaningful alerts as classified by the clinician

Time frame: 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

Data from ClinicalTrials.gov

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Unnamed facility

Mobile, Alabama, United States

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Mesa, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Fort Smith, Arkansas, United States

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Little Rock, Arkansas, United States

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East Palo Alto, California, United States

Unnamed facility

Inglewood, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Napa, California, United States

...and 117 more locations

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 1 month