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

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00402246
• Collaborator: Symbios Clinical (Other)
• Enrollment: 2,009
• Locations: 127
• Arms: 2
• Duration (Months): 34
• Patients Per Site: 15.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the ability of clinicians to receive and review information from patients implanted with a heart device over the internet (remote care) is comparable to patients who are seen in-office for routine visits to check the status of their device.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmia; Tachycardia; Atrial Fibrillation; Ventricular Fibrillation	Other: Remote Management; Other: In-Office Care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2009 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remote Arm Remote Management	Other: Remote Management; The Remote Management method of treating patients consists of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action.
Active Comparator: In-office Arm In-Office Care	Other: In-Office Care; Routine in-office care

Outcome Measures

Primary Outcome Measures

1. Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues [Enrollment to last visit (up to 15 month post-implant)]

   Days from device detection of a clinical event to a decision being made in response to the event, as reported by the clinician or as evidenced by device data obtained at interrogation. A clinical event could be any of the following that satisfied pre-specified thresholds: arrhythmias (e.g. at least 12 hours of atrial tachycard/atrial fibrillation in a day), cardiovascular disease progression (e.g. multiple device shocks delivered to terminate a single episode), or device issues (e.g. low battery).

Secondary Outcome Measures

1. Health Care Utilization (HCU) [Enrollment to last visit (up to 15 month post-implant)]

   Count of HCU visits for each HCU type (cardiovascular (CV) hospitalizations, cardiovascular (CV) emergency department (ED), and cardiovascular (CV) unscheduled clinic office/urgent care visits)

2. Health Care Utilization: TEEs [Enrollment to last visit (up to 15 months post-implant)]

   Count of Transesophageal echocardiograms (TEEs) performed

3. Actions Taken for HCU Visits [Enrollment to last visit (up to 15 month post-implant)]

   Count of HCU visits that involved specific actions taken

4. Clinically Meaningful Alerts [Enrollment to last visit (up to 15 month post-implant)]

   Count of clinically meaningful alerts as classified by the clinician

5. Symptomatic AT/AF Alerts [Enrollment to last visit (up to 15 month post-implant)]

   AT/AF represents atrial tachycardia or atrial fibrillation which are arrhythmias involving rapid beating of the atrial chambers of the heart. The devices in this study store how many hours each day that a patient experiences AT/AF. The patient may not be aware they are experiencing these atrial arrhythmias, but if the AT/AF is accompanied by symptoms, the AT/AF is said to be symptomatic AT/AF. Devices in this study have an alert that fires if the patient experiences at least a programmed amount of AT/AF in a day. Measure is count of symptomatic AT/AF alerts as classified by the clinician

6. AT/AF Alert Treatment [Enrollment to last visit (up to 15 month post-implant)]

   Count of the treatment (i.e. hospitalization, ED visit, unscheduled clinic office/urgent care visits) in response to the AT/AF alerts

7. Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations [Enrollment to last visit (up to 15 month post-implant)]

   Days from a symptom-driven device interrogation event onset to a clinical decision being made in response to the event as reported by the clinician. An event is defined as a subject complaint received by the managing clinician in which the clinician determines that he/she must interrogate the subject's device to properly treat the subject.

8. Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations [From event onset to clinical decision]

   Days from device detection of a clinical event or a symptom-driven device interrogation event onset to a clinical decision, as reported by the clinician or as evidenced by device data obtained at interrogation. A clinical event is an event as defined in the primary objective. A symptom-driven device interrogation event is defined as a subject complaint received by the managing clinician in which the clinician determines that he/she must interrogate the subject's device to properly treat the subject.

9. CareLink Transmission Compliance [3, 6, 9, 12 months visits]

   The CareLink Transmission Compliance Rate for a particular visit (e.g. 3 month visit) is the proportion (ranging from 0 to 1) of subjects with device interrogation data remotely transmitted via the CareLink system on the date it was scheduled to be sent for that visit. The proportion is a fraction in which the denominator is the number of subjects in the Remote Arm who were not exited from the trial prior to the visit of interest, and the numberator is the number of Remote Arm subjects who successfully transmitted device data via the CareLink system on the date it was scheduled to be sent.

10. Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM) [1, 3, 6, 9, 12, and 15 months visits]

    LV Capture Threshold is the required energy(volts) necessary to cause the left ventricule to contract. It is important that a device which paces the left ventricule be set to a threshold such that current conducted through the left ventricular lead will induce contraction in the left ventricle. However, these thresholds may vary over time. The standard deviation and range (maximum LVCM threshold - minimum LVCM threshold) of the most recent 14 days of LVCM results prior to each follow-up visit were determined for each subject and used to assess within-patient variability in LV thresholds.

11. State-Anxiety Scale [1, 3, 6, 9, 12, and 15 month visit]

    The State-Anxiety scales for each subject were obtained at multiple time points. The State-Anxiety scale was derived by summing the 20 scores in the State section of the State-Trait Anxiety Inventory (STAI) questionnaire. The State-Anxiety scales can vary from a minimum of 20 (best possible) to a maximum of 80 (worst possible).

12. Trait-Anxiety Scale [1, 3, 6, 9, 12, and 15 months visits]

    The Trait-Anxiety scales for each subject were obtained at multiple time points. The Trait-Anxiety scale was derived by summing the 20 scores in the Trait section of the STAI questionnaire. The Trait-Anxiety scales can vary from a minimum of 20 (best possible) to a maximum of 80 (worst possible).

13. Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG). [After study enrollment has been completed; on average 15.8 months after the center had enrolled its first subject]

    Following the completion of enrollment in the study, participating clinicians were asked to complete a survey assessing their overall satisfaction with the wireless telemetry feature. Clinicians' rating (1=strongly disagree, 5=strongly agree) of the overall satisfaction with the wireless telemetry feature of the device

14. In-office Follow-up Burden: Distance Traveled [1 month visit]

    Subjects' responses to the survey. Subjects were asked to provide the distance (in miles) from their home to the clinic/hospital.

15. In-office Follow-up Burden: Patient Expenses [1 month]

    On a survey at the one month visit, the patient estimated their expenses in traveling to that visit.

16. In-office Follow-up Burden: Hours Absent From Work Due to Visit [1 month]

    Subjects were asked at their one month visit to indicate on a survey how many hours of work they were missing to attend that visit.

Other Outcome Measures

1. Length of Hospital Stay (LOS) [Enrollment to last visit (up to 15 month post-implant)]

   LOS per cardiovascular hospitalization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient will be implanted with a Medtronic Conexus-enabled Cardiac Resynchronization Therapy Defibrillator (CRT-D) or Implantable Cardioverter-Defibrillator (DR-ICD) device.

Exclusion Criteria:

• Patient has permanent rapid beats in the upper chamber of the heart (Atrial Fibrillation) - (constant atrial fibrillation in which pharmacological therapy or cardioversion failed or not attempted).

• Patient plans to be on chronic warfarin therapy post-implant and is no longer receiving therapies to attempt to control the rhythm of the beats in their atrium.

• Patient has a previous ICD, CRT-D, Implantable Pulse Generator (IPG) or Cardiac Resynchronization Therapy Pacemaker (CRT-P).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Mobile	Alabama	United States
2		Mesa	Arizona	United States
3		Scottsdale	Arizona	United States
4		Tucson	Arizona	United States
5		Fort Smith	Arkansas	United States
6		Little Rock	Arkansas	United States
7		East Palo Alto	California	United States
8		Inglewood	California	United States
9		Los Angeles	California	United States
10		Napa	California	United States
11		Rancho Mirage	California	United States
12		San Bernardino	California	United States
13		San Diego	California	United States
14		Santa Rosa	California	United States
15		Colorado Springs	Colorado	United States
16		Bridgeport	Connecticut	United States
17		Washington	District of Columbia	United States
18		Brooksville	Florida	United States
19		Clearwater	Florida	United States
20		Daytona Beach	Florida	United States
21		Hollywood	Florida	United States
22		Jacksonville	Florida	United States
23		Lakeland	Florida	United States
24		Orlando	Florida	United States
25		Pensacola	Florida	United States
26		Safety Harbor	Florida	United States
27		Sarasota	Florida	United States
28		St. Petersburg	Florida	United States
29		Tampa	Florida	United States
30		Vero Beach	Florida	United States
31		Atlanta	Georgia	United States
32		Gainesville	Georgia	United States
33		Aurora	Illinois	United States
34		Chicago	Illinois	United States
35		Kankakee	Illinois	United States
36		Moline	Illinois	United States
37		Rockford	Illinois	United States
38		Springfield	Illinois	United States
39		Bloomington	Indiana	United States
40		Evansville	Indiana	United States
41		Indianapolis	Indiana	United States
42		Ames	Iowa	United States
43		Kansas City	Kansas	United States
44		Overland Park	Kansas	United States
45		Ashland	Kentucky	United States
46		Louisville	Kentucky	United States
47		Owensboro	Kentucky	United States
48		Covington	Louisiana	United States
49		Baltimore	Maryland	United States
50		Glen Burnie	Maryland	United States
51		Lanham	Maryland	United States
52		Randallstown	Maryland	United States
53		Salisbury	Maryland	United States
54		Takoma Park	Maryland	United States
55		Boston	Massachusetts	United States
56		Chelmsford	Massachusetts	United States
57		Ann Arbor	Michigan	United States
58		Grand Blanc	Michigan	United States
59		Petoskey	Michigan	United States
60		Saginaw	Michigan	United States
61		Saint Joseph	Michigan	United States
62		Ypsilanti	Michigan	United States
63		Minneapolis	Minnesota	United States
64		Saint Paul	Minnesota	United States
65		St. Cloud	Minnesota	United States
66		Hattiesburg	Mississippi	United States
67		Columbia	Missouri	United States
68		Mexico	Missouri	United States
69		Saint Louis	Missouri	United States
70		Springfield	Missouri	United States
71		Kearney	Nebraska	United States
72		Omaha	Nebraska	United States
73		Manchester	New Hampshire	United States
74		Cherry Hill	New Jersey	United States
75		Newark	New Jersey	United States
76		Ridgewood	New Jersey	United States
77		Wayne	New Jersey	United States
78		West Orange	New Jersey	United States
79		Flushing	New York	United States
80		Mineola	New York	United States
81		New York	New York	United States
82		Poughkeepsie	New York	United States
83		Rochester	New York	United States
84		Williamsville	New York	United States
85		Gastonia	North Carolina	United States
86		Raleigh	North Carolina	United States
87		Winston Salem	North Carolina	United States
88		Bismarck	North Dakota	United States
89		Cincinnati	Ohio	United States
90		Cleveland	Ohio	United States
91		Dayton	Ohio	United States
92		Fairview Park	Ohio	United States
93		Kettering	Ohio	United States
94		Mayfield Heights	Ohio	United States
95		Whitehall	Ohio	United States
96		Oklahoma City	Oklahoma	United States
97		Eugene	Oregon	United States
98		Portland	Oregon	United States
99		Abington	Pennsylvania	United States
100		Doylestown	Pennsylvania	United States
101		Erie	Pennsylvania	United States
102		Lancaster	Pennsylvania	United States
103		Langhorne	Pennsylvania	United States
104		Philadelphia	Pennsylvania	United States
105		Wormleysburg	Pennsylvania	United States
106		Wyomissing	Pennsylvania	United States
107		York	Pennsylvania	United States
108		Columbia	South Carolina	United States
109		Florence	South Carolina	United States
110		Greenwood	South Carolina	United States
111		Chattanooga	Tennessee	United States
112		Germantown	Tennessee	United States
113		Knoxville	Tennessee	United States
114		Nashville	Tennessee	United States
115		Amarillo	Texas	United States
116		Corpus Christi	Texas	United States
117		Dallas	Texas	United States
118		Houston	Texas	United States
119		San Antonio	Texas	United States
120		Woodlands	Texas	United States
121		Fairfax	Virginia	United States
122		Fredericksburg	Virginia	United States
123		Lynchburg	Virginia	United States
124		Portsmouth	Virginia	United States
125		Morgantown	West Virginia	United States
126		Madison	Wisconsin	United States
127		Milwaukee	Wisconsin	United States

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure
• Symbios Clinical

Investigators

• Principal Investigator: George Crossley, M.D., Mid-State Cardiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00402246
• Other Study ID Numbers: 605
• First Posted: Nov 22, 2006
• Last Update Posted: Feb 25, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: Randomized Controlled Trials; Defibrillators; Remote Consultation
• Additional relevant MeSH terms: Atrial Fibrillation; Tachycardia; Ventricular Fibrillation

Study Results

Participant Flow

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 Detail	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
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

Baseline Characteristics

Arm/Group Title	Remote Arm	In-Office Arm	Total
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 Participants	1014	983	1997
Age (Count of Participants)
<=18 years	0 0%	1 0.1%	1 0.1%
Between 18 and 65 years	453 44.7%	442 45%	895 44.8%
>=65 years	561 55.3%	540 54.9%	1101 55.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.2 (12.4)	64.9 (11.9)	65.0 (12.1)
Sex: Female, Male (Count of Participants)
Female	299 29.5%	278 28.3%	577 28.9%
Male	715 70.5%	705 71.7%	1420 71.1%
Region of Enrollment (participants) [Number]
United States	1014 100%	983 100%	1997 100%

Outcome Measures

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
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)

Outcome Measure Data

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
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
Measure Participants	172	145
Median (Inter-Quartile Range) [days]	4.6	22.0

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
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
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	17.4
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Health Care Utilization (HCU)
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)

Outcome Measure Data

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
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
Measure Participants	1005	975
CV hospitalizations	567	508
Emergency department (ED)	270	223
CV unscheduled clinic office/urgent care visits	2545	2114

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
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%; to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
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%; to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
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%; to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Health Care Utilization: TEEs
Description	Count of Transesophageal echocardiograms (TEEs) performed
Time Frame	Enrollment to last visit (up to 15 months post-implant)

Outcome Measure Data

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
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
Measure Participants	1005	975
Number [Procedures]	26	17

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
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
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.45
	Confidence Interval	(1-Sided) 95%; to 2.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Actions Taken for HCU Visits
Description	Count of HCU visits that involved specific actions taken
Time Frame	Enrollment to last visit (up to 15 month post-implant)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remote Arm	In-Office Arm
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
Measure Participants	1005	975
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
Description	Count of clinically meaningful alerts as classified by the clinician
Time Frame	Enrollment to last visit (up to 15 month post-implant)

Outcome Measure Data

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
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.
Measure Participants	170
Measure Events	379
Number [Alerts]	238

6. Secondary Outcome

Title	Symptomatic AT/AF Alerts
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)

Outcome Measure Data

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
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.
Measure Participants	107
Measure Events	255
Number [Alerts]	73

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remote Arm
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	probability
	Estimated Value	0.23
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	AT/AF Alert Treatment
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)

Outcome Measure Data

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
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.
Measure Participants	112
Measure Events	287
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
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)

Outcome Measure Data

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
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
Measure Participants	208	154
Mean (Standard Deviation) [Days]	0.8 (4.9)	0.7 (3.3)

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
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
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

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
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

Outcome Measure Data

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
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
Measure Participants	324	265
Mean (Standard Deviation) [Days]	6.7 (13.3)	16.7 (24.4)

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
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
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

10. Other Pre-specified Outcome

Title	Length of Hospital Stay (LOS)
Description	LOS per cardiovascular hospitalization
Time Frame	Enrollment to last visit (up to 15 month post-implant)

Outcome Measure Data

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
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
Measure Participants	336	333
Mean (Standard Error) [Days]	3.3 (0.15)	4.0 (0.18)

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
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
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.7 to 0.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	CareLink Transmission Compliance
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

Outcome Measure Data

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
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.
Measure Participants	1005
3 Month CareLink Transmission Compliance Rate	0.761
6 Month CareLink Transmission Compliance Rate	0.815
9 Month CareLink Transmission Compliance Rate	0.815
12 Month CareLink Transmission Compliance Rate	0.814

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Remote Arm
	Comments	3-month compliance rate
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	compliance rate
	Estimated Value	0.761
	Confidence Interval	(1-Sided) 95%; 0.737 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Remote Arm
	Comments	6-month compliance rate
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	compliance rate
	Estimated Value	0.815
	Confidence Interval	(1-Sided) 95%; 0.793 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Remote Arm
	Comments	9-month compliance rate
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	compliance rate
	Estimated Value	0.815
	Confidence Interval	(1-Sided) 95%; 0.792 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Remote Arm
	Comments	12-month compliance rate
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	compliance rate
	Estimated Value	0.814
	Confidence Interval	(1-Sided) 95%; 0.79 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
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

Outcome Measure Data

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
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
Measure Participants	604
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)

13. Secondary Outcome

Title	State-Anxiety Scale
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

Outcome Measure Data

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
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
Measure Participants	484	419
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)

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
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.

14. Secondary Outcome

Title	Trait-Anxiety Scale
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

Outcome Measure Data

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
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
Measure Participants	459	393
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)

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
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.

15. Secondary Outcome

Title	Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).
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

Outcome Measure Data

Analysis Population Description

All surveys in which clinician completed at least a subset of the questions were included.

Arm/Group Title	Clinicians
Arm/Group Description	Clinicians who responded to the survey
Measure Participants	212
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)

16. Secondary Outcome

Title	In-office Follow-up Burden: Distance Traveled
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

Outcome Measure Data

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
Arm/Group Description	All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
Measure Participants	1854
Mean (Standard Deviation) [Miles]	49.2 (63.4)

17. Secondary Outcome

Title	In-office Follow-up Burden: Patient Expenses
Description	On a survey at the one month visit, the patient estimated their expenses in traveling to that visit.
Time Frame	1 month

Outcome Measure Data

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
Arm/Group Description	All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
Measure Participants	1854
Mean (Standard Deviation) [Dollars]	15.0 (21.0)

18. Secondary Outcome

Title	In-office Follow-up Burden: Hours Absent From Work Due to Visit
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

Outcome Measure Data

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
Arm/Group Description	All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
Measure Participants	1854
Mean (Standard Deviation) [Hours]	4.4 (3.5)

Adverse Events

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
Arm/Group Description	All enrolled subjects in the study
All Cause Mortality
	Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Enrolled Subjects
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

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Principal Investigators are NOT employed by the organization sponsoring the study.

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.