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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Arrhythmia
Tachycardia
Atrial Fibrillation
Ventricular Fibrillation
Interventions Other: Remote Management
Other: In-Office Care
Enrollment 2009
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Remote Arm In-Office Arm
Hide Arm/Group Description

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 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
Period Title: Overall Study
Started 1014 983
Completed 794 749
Not Completed 220 234
Reason Not Completed
Death             62             58
Lost to Follow-up             20             28
Withdrawal by Subject             72             87
Physician Decision             24             26
Protocol Violation             25             24
Missed Final Visit             1             2
Insurance Issues             2             1
Heart Transplant             0             1
Patient's device explanted             6             2
Center Closure             5             3
Deterioriating Condition             3             2
Arm/Group Title Remote Arm In-Office Arm Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 1014 983 1997
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1014 participants 983 participants 1997 participants
<=18 years
0
   0.0%
1
   0.1%
1
   0.1%
Between 18 and 65 years
453
  44.7%
442
  45.0%
895
  44.8%
>=65 years
561
  55.3%
540
  54.9%
1101
  55.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1014 participants 983 participants 1997 participants
65.2  (12.4) 64.9  (11.9) 65.0  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1014 participants 983 participants 1997 participants
Female
299
  29.5%
278
  28.3%
577
  28.9%
Male
715
  70.5%
705
  71.7%
1420
  71.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1014 participants 983 participants 1997 participants
1014 983 1997
1.Primary Outcome
Title Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Remote Arm In-Office Arm
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 172 145
Median (Inter-Quartile Range)
Unit of Measure: days
4.6
(1.0 to 13.3)
22.0
(7.0 to 44.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remote Arm, In-Office Arm
Comments The null hypothesis is that the time from a clinical event to a clinical decision for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for significance was an alpha level of 0.05.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 17.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Health Care Utilization (HCU)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Remote Arm In-Office Arm
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 1005 975
Measure Type: Number
Unit of Measure: Visits
CV hospitalizations 567 508
Emergency department (ED) 270 223
CV unscheduled clinic office/urgent care visits 2545 2114
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remote Arm, In-Office Arm
Comments An Andersen‐Gill proportional hazards regression model was fit to test the hypothesis that the CV hospitalization hazard rates for patients in the remote arm is equal to that of similar patients in the in-office arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.524
Comments Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.
Method Andersen-Gill model
Comments An Andersen-Gill model was utilized to account for multiple hospitalization events per subject.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval (1-Sided) 95%
1.21
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remote Arm, In-Office Arm
Comments An Andersen‐Gill proportional hazards regression model was fit to test the hypothesis that the ED hazard rates for patients in the remote arm is equal to that of similar patients in the in-office arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.325
Comments Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.
Method Andersen-Gill model
Comments An Andersen-Gill model was utilized to account for multiple ED visits per subject.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.14
Confidence Interval (1-Sided) 95%
1.43
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Remote Arm, In-Office Arm
Comments An Andersen‐Gill proportional hazards regression model was fit to test the hypothesis that the hazard rates of the CV unscheduled clinic or urgent care visits for patients in the remote arm is equal to that of similar patients in the in-office arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.099
Comments Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.
Method Andersen-Gill model
Comments An Andersen-Gill model was utilized to account for multiple unscheduled clinic visits per subject.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.14
Confidence Interval (1-Sided) 95%
1.31
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Health Care Utilization: TEEs
Hide Description Count of Transesophageal echocardiograms (TEEs) performed
Time Frame Enrollment to last visit (up to 15 months post-implant)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Remote Arm In-Office Arm
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 1005 975
Measure Type: Number
Unit of Measure: Procedures
26 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remote Arm, In-Office Arm
Comments An Andersen‐Gill proportional hazards regression model was fit to test the hypothesis that the hazard rate of transesophageal echocardiography (TEE) taken for patients in the remote arm is equal to that of similar patients in the in-office arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.
Method Andersen-Gill model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.45
Confidence Interval (1-Sided) 95%
2.56
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Actions Taken for HCU Visits
Hide Description Count of HCU visits that involved specific actions taken
Time Frame Enrollment to last visit (up to 15 month post-implant)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remote Arm In-Office Arm
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 1005 975
Measure Type: Number
Unit of Measure: Visits
Total # of HCU visits 3869 2895
Total # of HCU visits with no Action Taken 687 513
Total # of HCU visits with TEE 26 17
Total # of HCU visits with Echo 221 218
Total # of HCU visits with EKG 670 514
Total # of HCU visits with device interrogation 903 531
#of HCU visits with oral CV medication change 771 710
# of HCU visits with IV CV medication administered 225 194
Total # of HCU visits with device reprogramming 429 170
#of HCU visits with surgical/invasive procedure 60 54
Total # of HCU visits with system modification 32 56
Total # of HCU visits with diagnostic test ordered 298 260
Total # of HCU visits with calling subject 137 3
Total # of HCU visits with bringing into clinic 143 27
# of HCU visits with referring to another clinic 85 52
Total # of HCU visits with admission to hospital 197 150
# of HCU visits with waiting till next clinic appt 41 29
Total # of HCU visits with sending to ED 12 5
Total # of HCU visits with blood test(s) 1089 1004
Total # of HCU visits with chest x-ray 380 328
Total # of HCU visits with exercise testing 36 23
Total # of HCU visits with EP study 16 11
Total # of HCU visits with cardioversion 37 22
Total # of HCU visits with other imaging 76 76
Total # of HCU visits with wound check 130 111
Total # of HCU visits - other action taken 396 285
#of HCU visits with defibrillation threshold test 116 68
#of HCU visits with pacing threshold testing 341 213
#of HCU visits with other device testing 130 89
5.Secondary Outcome
Title Clinically Meaningful Alerts
Hide Description Count of clinically meaningful alerts as classified by the clinician
Time Frame Enrollment to last visit (up to 15 month post-implant)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Remote Arm
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 170
Overall Number of Units Analyzed
Type of Units Analyzed: Events
379
Measure Type: Number
Unit of Measure: Alerts
238
6.Secondary Outcome
Title Symptomatic AT/AF Alerts
Hide Description 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
Time Frame Enrollment to last visit (up to 15 month post-implant)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Remote Arm
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 107
Overall Number of Units Analyzed
Type of Units Analyzed: Events
255
Measure Type: Number
Unit of Measure: Alerts
73
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remote Arm
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments A GEE model was utilized to account for multiple events within same patient in estimating the probability of an AT/AF alert event being symptomatic.
Method of Estimation Estimation Parameter probability
Estimated Value 0.23
Estimation Comments [Not Specified]
7.Secondary Outcome
Title AT/AF Alert Treatment
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled remote patients who had at least one AT/AF alert were included in the analysis.
Arm/Group Title Remote Arm
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 112
Overall Number of Units Analyzed
Type of Units Analyzed: Events
287
Measure Type: Number
Unit of Measure: Alerts
No Treatment 159
ED 2
Hospitalization 23
Unscheduled Clinic Office/Urgent Care Visits 89
Other Treatment 30
8.Secondary Outcome
Title Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis.
Arm/Group Title Remote Arm In-Office Arm
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 208 154
Mean (Standard Deviation)
Unit of Measure: Days
0.8  (4.9) 0.7  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remote Arm, In-Office Arm
Comments The null hypothesis is that the time from event onset to clinical decision for symptom-driven device interrogations for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.779
Comments The a priori threshold for significance was an alpha level of 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.8 to 1.0
Parameter Dispersion
Type: Standard Deviation
Value: 4.3
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis.
Arm/Group Title Remote Arm In-Office Arm
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 324 265
Mean (Standard Deviation)
Unit of Measure: Days
6.7  (13.3) 16.7  (24.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remote Arm
Comments The null hypothesis is the time from event onset to clinical decision for both device events and symptom-driven device interrogations for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The a priori threshold for significance was an alpha level of 0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.0
Confidence Interval (2-Sided) 95%
-13.1 to -6.9
Parameter Dispersion
Type: Standard Deviation
Value: 19.1
Estimation Comments [Not Specified]
10.Secondary Outcome
Title CareLink Transmission Compliance
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Remote Arm
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 1005
Mean (95% Confidence Interval)
Unit of Measure: Proportion of subjects
3 Month CareLink Transmission Compliance Rate
0.761
(0.737 to 1.00)
6 Month CareLink Transmission Compliance Rate
0.815
(0.793 to 1.00)
9 Month CareLink Transmission Compliance Rate
0.815
(0.792 to 1.00)
12 Month CareLink Transmission Compliance Rate
0.814
(0.790 to 1.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remote Arm
Comments 3-month compliance rate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Binomial Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter compliance rate
Estimated Value 0.761
Confidence Interval (1-Sided) 95%
0.737
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remote Arm
Comments 6-month compliance rate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Binomial Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter compliance rate
Estimated Value 0.815
Confidence Interval (1-Sided) 95%
0.793
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Remote Arm
Comments 9-month compliance rate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Binomial Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter compliance rate
Estimated Value 0.815
Confidence Interval (1-Sided) 95%
0.792
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Remote Arm
Comments 12-month compliance rate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Binomial Exact Test
Comments [Not Specified]
Method of Estimation Estimation Parameter compliance rate
Estimated Value 0.814
Confidence Interval (1-Sided) 95%
0.79
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
Hide Description

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
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Hide Analysis Population Description
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.
Arm/Group Title Patients With a Study CRT-D Device
Hide Arm/Group Description:
Patients in either the Remote Arm or the In-office Arm who were implanted with a study CRT-D Device, as these are the only devices that have Left Ventricular leads
Overall Number of Participants Analyzed 604
Mean (Standard Deviation)
Unit of Measure: Volts
1 month standard deviation 0.181  (0.202)
3 month standard deviation 0.117  (0.142)
6 month standard deviation 0.118  (0.138)
9 month standard deviation 0.121  (0.154)
12 month standard deviation 0.132  (0.142)
15 month standard deviation 0.135  (0.149)
1 month range 0.500  (0.606)
3 month range 0.324  (0.418)
6 month range 0.326  (0.419)
9 month range 0.345  (0.476)
12 month range 0.374  (0.428)
15 month range 0.381  (0.459)
12.Secondary Outcome
Title State-Anxiety Scale
Hide Description 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
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Hide Analysis Population Description
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.
Arm/Group Title Remote Arm In-Office Arm
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 484 419
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1 month 31.0  (10.9) 32.1  (12.0)
3 month 30.3  (10.6) 31.6  (11.8)
6 month 30.0  (11.1) 30.7  (11.0)
9 month 30.5  (11.5) 30.6  (11.2)
12 month 30.2  (11.7) 31.2  (12.0)
15 month 31.0  (12.4) 32.7  (12.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remote Arm, In-Office Arm
Comments A mixed model was fit to test whether patients followed through the remote management system will experience less anxiety than patients followed through in-office care.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.217
Comments The a prior threshold for statistical significance was 0.05.
Method Mixed Models Analysis
Comments Model was fit with randomization arm, device group (CRT-D vs. DR-ICD), and follow-up visit as fixed effects, and subject as a random effect.
13.Secondary Outcome
Title Trait-Anxiety Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Remote Arm In-Office Arm
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 459 393
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
1 month 31.2  (10.5) 32.1  (11.4)
3 month 29.8  (9.6) 31.3  (11.3)
6 month 29.6  (10.3) 30.8  (10.7)
9 month 29.7  (10.6) 30.6  (10.9)
12 month 29.6  (10.7) 30.5  (11.5)
15 month 30.7  (11.1) 30.8  (11.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remote Arm, In-Office Arm
Comments A mixed model was fit to test whether patients followed through the remote management system will experience less anxiety than patients followed through in-office care.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.154
Comments The a priori threshold for statistical significance for was 0.05.
Method Mixed Models Analysis
Comments Model was fit with randomization arm, device group (CRT-D vs. DR-ICD), and follow-up visit as fixed effects, and subject as a random effect.
14.Secondary Outcome
Title Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All surveys in which clinician completed at least a subset of the questions were included.
Arm/Group Title Clinicians
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Clinicians who responded to the survey
Overall Number of Participants Analyzed 212
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Satisfaction with the Full-Wireless follow-up 4.3  (0.8)
Prefer to perform wireless follow-up 4.0  (1.0)
Prefer to use leadless ECG during follow-up 3.8  (1.0)
Pts were more comfortable with wireless follow-up 4.2  (1.0)
Treated pts sooner due to wireless CareAlerts 4.0  (0.9)
Provided better pt care due to wireless CareAlerts 3.9  (0.9)
15.Secondary Outcome
Title In-office Follow-up Burden: Distance Traveled
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.
Arm/Group Title Enrolled Subjects
Hide Arm/Group Description:
All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
Overall Number of Participants Analyzed 1854
Mean (Standard Deviation)
Unit of Measure: Miles
49.2  (63.4)
16.Secondary Outcome
Title In-office Follow-up Burden: Patient Expenses
Hide Description On a survey at the one month visit, the patient estimated their expenses in traveling to that visit.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.
Arm/Group Title Enrolled Subjects
Hide Arm/Group Description:
All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
Overall Number of Participants Analyzed 1854
Mean (Standard Deviation)
Unit of Measure: Dollars
15.0  (21.0)
17.Secondary Outcome
Title In-office Follow-up Burden: Hours Absent From Work Due to Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.
Arm/Group Title Enrolled Subjects
Hide Arm/Group Description:
All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
Overall Number of Participants Analyzed 1854
Mean (Standard Deviation)
Unit of Measure: Hours
4.4  (3.5)
18.Other Pre-specified Outcome
Title Length of Hospital Stay (LOS)
Hide Description LOS per cardiovascular hospitalization
Time Frame Enrollment to last visit (up to 15 month post-implant)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects who satisfied the inclusion/exclusion criteria and had at least one cardiovascular hospitalization were included in the analysis.
Arm/Group Title Remote Arm In-Office Arm
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 336 333
Mean (Standard Error)
Unit of Measure: Days
3.3  (0.15) 4.0  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remote Arm, In-Office Arm
Comments The null hypothesis was that the mean LOS per hospitalization visit for patients in the remote arm was equal to that for similar patients in the in-office arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The a priori threshold for statistical significance was 0.05. The threshold was met, and the null hypothesis was rejected.
Method negative binomial model
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.7 to 0.9
Estimation Comments [Not Specified]
Time Frame Not applicable as adverse events were not collected in the CONNECT Study.
Adverse Event Reporting Description Products used in the study were market approved and used within labeling indications. Centers were instructed to report Unanticipated Adverse Device Events(UADE) in the manner required for any commercially available device: through the Medical Device Reporting(MDR) processes and in accordance with any reporting requirements required by their IRB.
 
Arm/Group Title Enrolled Subjects
Hide Arm/Group Description All enrolled subjects in the study
All-Cause Mortality
Enrolled Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Enrolled Subjects
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enrolled Subjects
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: CONNECT Clinical Trial Specialist
Organization: Medtronic, Inc
EMail: medtronicCRMtrials@medtronic.com
Layout table for additonal information
Responsible Party: CONNECT Trial Leader, Medtronic, Inc.
ClinicalTrials.gov Identifier: NCT00402246     History of Changes
Other Study ID Numbers: 605
First Submitted: November 17, 2006
First Posted: November 22, 2006
Results First Submitted: September 29, 2010
Results First Posted: February 16, 2011
Last Update Posted: February 25, 2011