Trial Outcomes & Findings for CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision (NCT NCT00402246)
NCT ID: NCT00402246
Last Updated: 2011-02-25
Results Overview
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).
COMPLETED
NA
2009 participants
Enrollment to last visit (up to 15 month post-implant)
2011-02-25
Participant Flow
The first enrollment occurred 29 November 2006. A total of 1997 subjects were enrolled (i.e. consented, implanted, and randomized) in the study from a total of 136 activated clinical study centers.
There were an additional 12 patients (for a total of 2009 patients) consented for whom proper permission to use their data could not be obtained. Any data obtained for these patients was excluded from all reporting.
Participant milestones
| Measure |
Remote Arm
Wireless remote monitoring, consisting 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 Arm
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
Overall Study
STARTED
|
1014
|
983
|
|
Overall Study
COMPLETED
|
794
|
749
|
|
Overall Study
NOT COMPLETED
|
220
|
234
|
Reasons for withdrawal
| Measure |
Remote Arm
Wireless remote monitoring, consisting 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 Arm
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
Overall Study
Death
|
62
|
58
|
|
Overall Study
Lost to Follow-up
|
20
|
28
|
|
Overall Study
Withdrawal by Subject
|
72
|
87
|
|
Overall Study
Physician Decision
|
24
|
26
|
|
Overall Study
Protocol Violation
|
25
|
24
|
|
Overall Study
Missed Final Visit
|
1
|
2
|
|
Overall Study
Insurance Issues
|
2
|
1
|
|
Overall Study
Heart Transplant
|
0
|
1
|
|
Overall Study
Patient's device explanted
|
6
|
2
|
|
Overall Study
Center Closure
|
5
|
3
|
|
Overall Study
Deterioriating Condition
|
3
|
2
|
Baseline Characteristics
CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision
Baseline characteristics by cohort
| Measure |
Remote Arm
n=1014 Participants
Wireless remote monitoring, consisting 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 Arm
n=983 Participants
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
Total
n=1997 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
453 Participants
n=5 Participants
|
442 Participants
n=7 Participants
|
895 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
561 Participants
n=5 Participants
|
540 Participants
n=7 Participants
|
1101 Participants
n=5 Participants
|
|
Age Continuous
|
65.2 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
299 Participants
n=5 Participants
|
278 Participants
n=7 Participants
|
577 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
715 Participants
n=5 Participants
|
705 Participants
n=7 Participants
|
1420 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1014 participants
n=5 Participants
|
983 participants
n=7 Participants
|
1997 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Enrollment to last visit (up to 15 month post-implant)Population: All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis. An intention to treat analysis was performed for this objective.
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).
Outcome measures
| Measure |
Remote Arm
n=172 Participants
Wireless remote monitoring, consisting 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 Arm
n=145 Participants
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues
|
4.6 days
Interval 1.0 to 13.3
|
22.0 days
Interval 7.0 to 44.2
|
SECONDARY outcome
Timeframe: Enrollment to last visit (up to 15 month post-implant)Population: 9 remote arm patients and 8 in-office arm patients did not meet the inclusion/exclusion criteria. The remaining 1005 remote arm patients and 975 in-office arm patients were included in the analysis. An intention to treat analysis was performed for this objective.
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)
Outcome measures
| Measure |
Remote Arm
n=1005 Participants
Wireless remote monitoring, consisting 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 Arm
n=975 Participants
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
Health Care Utilization (HCU)
CV hospitalizations
|
567 Visits
|
508 Visits
|
|
Health Care Utilization (HCU)
Emergency department (ED)
|
270 Visits
|
223 Visits
|
|
Health Care Utilization (HCU)
CV unscheduled clinic office/urgent care visits
|
2545 Visits
|
2114 Visits
|
SECONDARY outcome
Timeframe: Enrollment to last visit (up to 15 months post-implant)Population: 9 remote arm patients and 8 in-office arm patients did not meet the inclusion/exclusion criteria. The remaining 1005 remote arm patients and 975 in-office arm patients were included in the analysis. An intention to treat analysis was performed for this objective.
Count of Transesophageal echocardiograms (TEEs) performed
Outcome measures
| Measure |
Remote Arm
n=1005 Participants
Wireless remote monitoring, consisting 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 Arm
n=975 Participants
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
Health Care Utilization: TEEs
|
26 Procedures
|
17 Procedures
|
SECONDARY outcome
Timeframe: Enrollment to last visit (up to 15 month post-implant)Count of HCU visits that involved specific actions taken
Outcome measures
| Measure |
Remote Arm
n=1005 Participants
Wireless remote monitoring, consisting 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 Arm
n=975 Participants
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
Actions Taken for HCU Visits
Total # of HCU visits - other action taken
|
396 Visits
|
285 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits
|
3869 Visits
|
2895 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with no Action Taken
|
687 Visits
|
513 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with TEE
|
26 Visits
|
17 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with Echo
|
221 Visits
|
218 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with EKG
|
670 Visits
|
514 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with device interrogation
|
903 Visits
|
531 Visits
|
|
Actions Taken for HCU Visits
#of HCU visits with oral CV medication change
|
771 Visits
|
710 Visits
|
|
Actions Taken for HCU Visits
# of HCU visits with IV CV medication administered
|
225 Visits
|
194 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with device reprogramming
|
429 Visits
|
170 Visits
|
|
Actions Taken for HCU Visits
#of HCU visits with surgical/invasive procedure
|
60 Visits
|
54 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with system modification
|
32 Visits
|
56 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with diagnostic test ordered
|
298 Visits
|
260 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with calling subject
|
137 Visits
|
3 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with bringing into clinic
|
143 Visits
|
27 Visits
|
|
Actions Taken for HCU Visits
# of HCU visits with referring to another clinic
|
85 Visits
|
52 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with admission to hospital
|
197 Visits
|
150 Visits
|
|
Actions Taken for HCU Visits
# of HCU visits with waiting till next clinic appt
|
41 Visits
|
29 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with sending to ED
|
12 Visits
|
5 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with blood test(s)
|
1089 Visits
|
1004 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with chest x-ray
|
380 Visits
|
328 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with exercise testing
|
36 Visits
|
23 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with EP study
|
16 Visits
|
11 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with cardioversion
|
37 Visits
|
22 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with other imaging
|
76 Visits
|
76 Visits
|
|
Actions Taken for HCU Visits
Total # of HCU visits with wound check
|
130 Visits
|
111 Visits
|
|
Actions Taken for HCU Visits
#of HCU visits with defibrillation threshold test
|
116 Visits
|
68 Visits
|
|
Actions Taken for HCU Visits
#of HCU visits with pacing threshold testing
|
341 Visits
|
213 Visits
|
|
Actions Taken for HCU Visits
#of HCU visits with other device testing
|
130 Visits
|
89 Visits
|
SECONDARY outcome
Timeframe: Enrollment to last visit (up to 15 month post-implant)Population: All enrolled remote subjects who experienced at least one alert were included in the analysis. Alerts that were not classified by the clinician as clinically meaningful or not were excluded from the analysis.
Count of clinically meaningful alerts as classified by the clinician
Outcome measures
| Measure |
Remote Arm
n=379 Events
Wireless remote monitoring, consisting 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 Arm
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
Clinically Meaningful Alerts
|
238 Alerts
|
—
|
SECONDARY outcome
Timeframe: Enrollment to last visit (up to 15 month post-implant)Population: All enrolled remote patients who experienced at least one AT/AF alert were included in the analysis. AT/AF alerts there were not classified by the clinician as symptomatic or asymptomatic were excluded from the analysis.
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
Outcome measures
| Measure |
Remote Arm
n=255 Events
Wireless remote monitoring, consisting 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 Arm
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
Symptomatic AT/AF Alerts
|
73 Alerts
|
—
|
SECONDARY outcome
Timeframe: Enrollment to last visit (up to 15 month post-implant)Population: All enrolled remote patients who had at least one AT/AF alert were included in the analysis.
Count of the treatment (i.e. hospitalization, ED visit, unscheduled clinic office/urgent care visits) in response to the AT/AF alerts
Outcome measures
| Measure |
Remote Arm
n=287 Events
Wireless remote monitoring, consisting 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 Arm
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
AT/AF Alert Treatment
No Treatment
|
159 Alerts
|
—
|
|
AT/AF Alert Treatment
ED
|
2 Alerts
|
—
|
|
AT/AF Alert Treatment
Hospitalization
|
23 Alerts
|
—
|
|
AT/AF Alert Treatment
Unscheduled Clinic Office/Urgent Care Visits
|
89 Alerts
|
—
|
|
AT/AF Alert Treatment
Other Treatment
|
30 Alerts
|
—
|
SECONDARY outcome
Timeframe: Enrollment to last visit (up to 15 month post-implant)Population: All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis.
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.
Outcome measures
| Measure |
Remote Arm
n=208 Participants
Wireless remote monitoring, consisting 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 Arm
n=154 Participants
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations
|
0.8 Days
Standard Deviation 4.9
|
0.7 Days
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: From event onset to clinical decisionPopulation: All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis.
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.
Outcome measures
| Measure |
Remote Arm
n=324 Participants
Wireless remote monitoring, consisting 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 Arm
n=265 Participants
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations
|
6.7 Days
Standard Deviation 13.3
|
16.7 Days
Standard Deviation 24.4
|
SECONDARY outcome
Timeframe: 3, 6, 9, 12 months visitsPopulation: 9 of 1014 remote arm subjects did not meet the inclusion/exclusion criteria and were excluded from the analysis. The remaining 1005 remote arm subjects were included in the analysis.
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.
Outcome measures
| Measure |
Remote Arm
n=1005 Participants
Wireless remote monitoring, consisting 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 Arm
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
CareLink Transmission Compliance
3 Month CareLink Transmission Compliance Rate
|
0.761 Proportion of subjects
Interval 0.737 to 1.0
|
—
|
|
CareLink Transmission Compliance
6 Month CareLink Transmission Compliance Rate
|
0.815 Proportion of subjects
Interval 0.793 to 1.0
|
—
|
|
CareLink Transmission Compliance
9 Month CareLink Transmission Compliance Rate
|
0.815 Proportion of subjects
Interval 0.792 to 1.0
|
—
|
|
CareLink Transmission Compliance
12 Month CareLink Transmission Compliance Rate
|
0.814 Proportion of subjects
Interval 0.79 to 1.0
|
—
|
SECONDARY outcome
Timeframe: 1, 3, 6, 9, 12, and 15 months visitsPopulation: All enrolled subjects who were implanted with a Concerto CRT-D (Cardiac Resynchronization Therapy with Defibrillation)device, met inclusion/exclusion criteria, and had daily LVCM measurement for at least one of the 6 scheduled visits/transmissions were included in the analysis.
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.
Outcome measures
| Measure |
Remote Arm
n=604 Participants
Wireless remote monitoring, consisting 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 Arm
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
1 month standard deviation
|
0.181 Volts
Standard Deviation 0.202
|
—
|
|
Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
3 month standard deviation
|
0.117 Volts
Standard Deviation 0.142
|
—
|
|
Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
6 month standard deviation
|
0.118 Volts
Standard Deviation 0.138
|
—
|
|
Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
9 month standard deviation
|
0.121 Volts
Standard Deviation 0.154
|
—
|
|
Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
12 month standard deviation
|
0.132 Volts
Standard Deviation 0.142
|
—
|
|
Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
15 month standard deviation
|
0.135 Volts
Standard Deviation 0.149
|
—
|
|
Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
1 month range
|
0.500 Volts
Standard Deviation 0.606
|
—
|
|
Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
3 month range
|
0.324 Volts
Standard Deviation 0.418
|
—
|
|
Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
6 month range
|
0.326 Volts
Standard Deviation 0.419
|
—
|
|
Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
9 month range
|
0.345 Volts
Standard Deviation 0.476
|
—
|
|
Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
12 month range
|
0.374 Volts
Standard Deviation 0.428
|
—
|
|
Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
15 month range
|
0.381 Volts
Standard Deviation 0.459
|
—
|
SECONDARY outcome
Timeframe: 1, 3, 6, 9, 12, and 15 month visitPopulation: All enrolled subjects who completed the STAI questionnaire for all scheduled follow-up visits/transmissions that occurred within specified visit windows and satisfied the inclusion/exclusion criteria were included in the analysis.
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).
Outcome measures
| Measure |
Remote Arm
n=484 Participants
Wireless remote monitoring, consisting 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 Arm
n=419 Participants
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
State-Anxiety Scale
1 month
|
31.0 Scores on a scale
Standard Deviation 10.9
|
32.1 Scores on a scale
Standard Deviation 12.0
|
|
State-Anxiety Scale
3 month
|
30.3 Scores on a scale
Standard Deviation 10.6
|
31.6 Scores on a scale
Standard Deviation 11.8
|
|
State-Anxiety Scale
6 month
|
30.0 Scores on a scale
Standard Deviation 11.1
|
30.7 Scores on a scale
Standard Deviation 11.0
|
|
State-Anxiety Scale
9 month
|
30.5 Scores on a scale
Standard Deviation 11.5
|
30.6 Scores on a scale
Standard Deviation 11.2
|
|
State-Anxiety Scale
12 month
|
30.2 Scores on a scale
Standard Deviation 11.7
|
31.2 Scores on a scale
Standard Deviation 12.0
|
|
State-Anxiety Scale
15 month
|
31.0 Scores on a scale
Standard Deviation 12.4
|
32.7 Scores on a scale
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: 1, 3, 6, 9, 12, and 15 months visitsPopulation: All enrolled subjects who completed the STAI questionnaire for all scheduled follow-up visits/transmissions that occurred within specified visit windows and satisfied the inclusion/exclusion criteria were included in the analysis.
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).
Outcome measures
| Measure |
Remote Arm
n=459 Participants
Wireless remote monitoring, consisting 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 Arm
n=393 Participants
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
Trait-Anxiety Scale
1 month
|
31.2 Scores on a scale
Standard Deviation 10.5
|
32.1 Scores on a scale
Standard Deviation 11.4
|
|
Trait-Anxiety Scale
3 month
|
29.8 Scores on a scale
Standard Deviation 9.6
|
31.3 Scores on a scale
Standard Deviation 11.3
|
|
Trait-Anxiety Scale
6 month
|
29.6 Scores on a scale
Standard Deviation 10.3
|
30.8 Scores on a scale
Standard Deviation 10.7
|
|
Trait-Anxiety Scale
9 month
|
29.7 Scores on a scale
Standard Deviation 10.6
|
30.6 Scores on a scale
Standard Deviation 10.9
|
|
Trait-Anxiety Scale
12 month
|
29.6 Scores on a scale
Standard Deviation 10.7
|
30.5 Scores on a scale
Standard Deviation 11.5
|
|
Trait-Anxiety Scale
15 month
|
30.7 Scores on a scale
Standard Deviation 11.1
|
30.8 Scores on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: After study enrollment has been completed; on average 15.8 months after the center had enrolled its first subjectPopulation: All surveys in which clinician completed at least a subset of the questions were included.
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
Outcome measures
| Measure |
Remote Arm
n=212 Participants
Wireless remote monitoring, consisting 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 Arm
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).
Prefer to perform wireless follow-up
|
4.0 Units on a scale
Standard Deviation 1.0
|
—
|
|
Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).
Satisfaction with the Full-Wireless follow-up
|
4.3 Units on a scale
Standard Deviation 0.8
|
—
|
|
Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).
Prefer to use leadless ECG during follow-up
|
3.8 Units on a scale
Standard Deviation 1.0
|
—
|
|
Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).
Pts were more comfortable with wireless follow-up
|
4.2 Units on a scale
Standard Deviation 1.0
|
—
|
|
Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).
Treated pts sooner due to wireless CareAlerts
|
4.0 Units on a scale
Standard Deviation 0.9
|
—
|
|
Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).
Provided better pt care due to wireless CareAlerts
|
3.9 Units on a scale
Standard Deviation 0.9
|
—
|
SECONDARY outcome
Timeframe: 1 month visitPopulation: All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.
Subjects' responses to the survey. Subjects were asked to provide the distance (in miles) from their home to the clinic/hospital.
Outcome measures
| Measure |
Remote Arm
n=1854 Participants
Wireless remote monitoring, consisting 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 Arm
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
In-office Follow-up Burden: Distance Traveled
|
49.2 Miles
Standard Deviation 63.4
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.
On a survey at the one month visit, the patient estimated their expenses in traveling to that visit.
Outcome measures
| Measure |
Remote Arm
n=1854 Participants
Wireless remote monitoring, consisting 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 Arm
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
In-office Follow-up Burden: Patient Expenses
|
15.0 Dollars
Standard Deviation 21.0
|
—
|
SECONDARY outcome
Timeframe: 1 monthPopulation: All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.
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.
Outcome measures
| Measure |
Remote Arm
n=1854 Participants
Wireless remote monitoring, consisting 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 Arm
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
In-office Follow-up Burden: Hours Absent From Work Due to Visit
|
4.4 Hours
Standard Deviation 3.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment to last visit (up to 15 month post-implant)Population: All enrolled subjects who satisfied the inclusion/exclusion criteria and had at least one cardiovascular hospitalization were included in the analysis.
LOS per cardiovascular hospitalization
Outcome measures
| Measure |
Remote Arm
n=336 Participants
Wireless remote monitoring, consisting 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 Arm
n=333 Participants
In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
|
|---|---|---|
|
Length of Hospital Stay (LOS)
|
3.3 Days
Standard Error 0.15
|
4.0 Days
Standard Error 0.18
|
Adverse Events
Enrolled Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigational Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication.
- Publication restrictions are in place
Restriction type: OTHER