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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00402246

Acronym

CONNECT

Enrollment

2009

Registered

2006-11-22

Start date

2006-11-30

Completion date

2009-09-30

Last updated

2011-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Atrial Fibrillation, Tachycardia, Ventricular Fibrillation

Keywords

Randomized Controlled Trials, Defibrillators, Remote Consultation

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.

Interventions

OTHERRemote 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.

OTHERIn-Office Care

Routine in-office care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
Health Care Utilization: TEEs	Enrollment to last visit (up to 15 months post-implant)	Count of Transesophageal echocardiograms (TEEs) performed
Actions Taken for HCU Visits	Enrollment to last visit (up to 15 month post-implant)	Count of HCU visits that involved specific actions taken
Clinically Meaningful Alerts	Enrollment to last visit (up to 15 month post-implant)	Count of clinically meaningful alerts as classified by the clinician
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
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
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.
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.
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.
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).
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).
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
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.
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.
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.
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.

Other

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

Countries

United States

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 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.

Participants by arm

Arm	Count
Remote Arm Wireless remote monitoring, consisting of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action.	1,014
In-Office Arm In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit	983
Total	1,997

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Center Closure	5	3
Overall Study	Death	62	58
Overall Study	Deterioriating Condition	3	2
Overall Study	Heart Transplant	0	1
Overall Study	Insurance Issues	2	1
Overall Study	Lost to Follow-up	20	28
Overall Study	Missed Final Visit	1	2
Overall Study	Patient's device explanted	6	2
Overall Study	Physician Decision	24	26
Overall Study	Protocol Violation	25	24
Overall Study	Withdrawal by Subject	72	87

Baseline characteristics

Characteristic	In-Office Arm	Remote Arm	Total
Age, Categorical <=18 years	1 Participants	0 Participants	1 Participants
Age, Categorical >=65 years	540 Participants	561 Participants	1101 Participants
Age, Categorical Between 18 and 65 years	442 Participants	453 Participants	895 Participants
Age Continuous	64.9 years STANDARD_DEVIATION 11.9	65.2 years STANDARD_DEVIATION 12.4	65.0 years STANDARD_DEVIATION 12.1
Region of Enrollment United States	983 participants	1014 participants	1997 participants
Sex: Female, Male Female	278 Participants	299 Participants	577 Participants
Sex: Female, Male Male	705 Participants	715 Participants	1420 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

Primary

Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues

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

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

Population: All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis. An intention to treat analysis was performed for this objective.

Arm	Measure	Value (MEDIAN)
Remote Arm	Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues	4.6 days
In-Office Arm	Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues	22.0 days

Comparison: 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.p-value: <0.001Wilcoxon (Mann-Whitney)

Secondary

Actions Taken for HCU Visits

Count of HCU visits that involved specific actions taken

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

Arm	Measure	Group	Value (NUMBER)
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with EP study	16 Visits
Remote Arm	Actions Taken for HCU Visits	# of HCU visits with IV CV medication administered	225 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits	3869 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with no Action Taken	687 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with TEE	26 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with Echo	221 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with EKG	670 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with device interrogation	903 Visits
Remote Arm	Actions Taken for HCU Visits	#of HCU visits with oral CV medication change	771 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with device reprogramming	429 Visits
Remote Arm	Actions Taken for HCU Visits	#of HCU visits with surgical/invasive procedure	60 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with system modification	32 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with diagnostic test ordered	298 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with calling subject	137 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with bringing into clinic	143 Visits
Remote Arm	Actions Taken for HCU Visits	# of HCU visits with referring to another clinic	85 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with admission to hospital	197 Visits
Remote Arm	Actions Taken for HCU Visits	# of HCU visits with waiting till next clinic appt	41 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with sending to ED	12 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with blood test(s)	1089 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with chest x-ray	380 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with exercise testing	36 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with cardioversion	37 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with other imaging	76 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits with wound check	130 Visits
Remote Arm	Actions Taken for HCU Visits	Total # of HCU visits - other action taken	396 Visits
Remote Arm	Actions Taken for HCU Visits	#of HCU visits with defibrillation threshold test	116 Visits
Remote Arm	Actions Taken for HCU Visits	#of HCU visits with pacing threshold testing	341 Visits
Remote Arm	Actions Taken for HCU Visits	#of HCU visits with other device testing	130 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with EP study	11 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with system modification	56 Visits
In-Office Arm	Actions Taken for HCU Visits	#of HCU visits with oral CV medication change	710 Visits
In-Office Arm	Actions Taken for HCU Visits	# of HCU visits with referring to another clinic	52 Visits
In-Office Arm	Actions Taken for HCU Visits	#of HCU visits with defibrillation threshold test	68 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits	2895 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with admission to hospital	150 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with no Action Taken	513 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with cardioversion	22 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with TEE	17 Visits
In-Office Arm	Actions Taken for HCU Visits	# of HCU visits with waiting till next clinic appt	29 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with Echo	218 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits - other action taken	285 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with EKG	514 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with sending to ED	5 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with device interrogation	531 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with other imaging	76 Visits
In-Office Arm	Actions Taken for HCU Visits	# of HCU visits with IV CV medication administered	194 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with blood test(s)	1004 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with device reprogramming	170 Visits
In-Office Arm	Actions Taken for HCU Visits	#of HCU visits with pacing threshold testing	213 Visits
In-Office Arm	Actions Taken for HCU Visits	#of HCU visits with surgical/invasive procedure	54 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with chest x-ray	328 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with wound check	111 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with diagnostic test ordered	260 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with exercise testing	23 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with calling subject	3 Visits
In-Office Arm	Actions Taken for HCU Visits	#of HCU visits with other device testing	89 Visits
In-Office Arm	Actions Taken for HCU Visits	Total # of HCU visits with bringing into clinic	27 Visits

Secondary

AT/AF Alert Treatment

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

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

Population: All enrolled remote patients who had at least one AT/AF alert were included in the analysis.

Arm	Measure	Group	Value (NUMBER)
Remote Arm	AT/AF Alert Treatment	Hospitalization	23 Alerts
Remote Arm	AT/AF Alert Treatment	No Treatment	159 Alerts
Remote Arm	AT/AF Alert Treatment	ED	2 Alerts
Remote Arm	AT/AF Alert Treatment	Unscheduled Clinic Office/Urgent Care Visits	89 Alerts
Remote Arm	AT/AF Alert Treatment	Other Treatment	30 Alerts

Secondary

CareLink Transmission Compliance

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

Time frame: 3, 6, 9, 12 months visits

Population: 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	Measure	Group	Value (MEAN)
Remote Arm	CareLink Transmission Compliance	3 Month CareLink Transmission Compliance Rate	0.761 Proportion of subjects
Remote Arm	CareLink Transmission Compliance	6 Month CareLink Transmission Compliance Rate	0.815 Proportion of subjects
Remote Arm	CareLink Transmission Compliance	9 Month CareLink Transmission Compliance Rate	0.815 Proportion of subjects
Remote Arm	CareLink Transmission Compliance	12 Month CareLink Transmission Compliance Rate	0.814 Proportion of subjects

Comparison: 3-month compliance rateBinomial Exact Test

Comparison: 6-month compliance rateBinomial Exact Test

Comparison: 9-month compliance rateBinomial Exact Test

Comparison: 12-month compliance rateBinomial Exact Test

Secondary

Clinically Meaningful Alerts

Count of clinically meaningful alerts as classified by the clinician

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

Population: All enrolled remote subjects who experienced at least one alert were included in the analysis. Alerts that were not classified by the clinician as clinically meaningful or not were excluded from the analysis.

Arm	Measure	Value (NUMBER)
Remote Arm	Clinically Meaningful Alerts	238 Alerts

Secondary

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

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

Time frame: After study enrollment has been completed; on average 15.8 months after the center had enrolled its first subject

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Remote Arm	Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).	Satisfaction with the Full-Wireless follow-up	4.3 Units on a scale	Standard Deviation 0.8
Remote Arm	Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).	Prefer to perform wireless follow-up	4.0 Units on a scale	Standard Deviation 1
Remote Arm	Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).	Prefer to use leadless ECG during follow-up	3.8 Units on a scale	Standard Deviation 1
Remote Arm	Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).	Pts were more comfortable with wireless follow-up	4.2 Units on a scale	Standard Deviation 1
Remote Arm	Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).	Treated pts sooner due to wireless CareAlerts	4.0 Units on a scale	Standard Deviation 0.9
Remote Arm	Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).	Provided better pt care due to wireless CareAlerts	3.9 Units on a scale	Standard Deviation 0.9

Secondary

Health Care Utilization (HCU)

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

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

Population: 9 remote arm patients and 8 in-office arm patients did not meet the inclusion/exclusion criteria. The remaining 1005 remote arm patients and 975 in-office arm patients were included in the analysis. An intention to treat analysis was performed for this objective.

Arm	Measure	Group	Value (NUMBER)
Remote Arm	Health Care Utilization (HCU)	CV hospitalizations	567 Visits
Remote Arm	Health Care Utilization (HCU)	Emergency department (ED)	270 Visits
Remote Arm	Health Care Utilization (HCU)	CV unscheduled clinic office/urgent care visits	2545 Visits
In-Office Arm	Health Care Utilization (HCU)	CV hospitalizations	508 Visits
In-Office Arm	Health Care Utilization (HCU)	Emergency department (ED)	223 Visits
In-Office Arm	Health Care Utilization (HCU)	CV unscheduled clinic office/urgent care visits	2114 Visits

Comparison: 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.p-value: 0.524Andersen-Gill model

Comparison: 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.p-value: 0.325Andersen-Gill model

Comparison: 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.p-value: 0.099Andersen-Gill model

Secondary

Health Care Utilization: TEEs

Count of Transesophageal echocardiograms (TEEs) performed

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

Arm	Measure	Value (NUMBER)
Remote Arm	Health Care Utilization: TEEs	26 Procedures
In-Office Arm	Health Care Utilization: TEEs	17 Procedures

Comparison: 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.p-value: 0.29Andersen-Gill model

Secondary

In-office Follow-up Burden: Distance Traveled

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

Time frame: 1 month visit

Population: All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.

Arm	Measure	Value (MEAN)	Dispersion
Remote Arm	In-office Follow-up Burden: Distance Traveled	49.2 Miles	Standard Deviation 63.4

Secondary

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

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

Time frame: 1 month

Population: All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.

Arm	Measure	Value (MEAN)	Dispersion
Remote Arm	In-office Follow-up Burden: Hours Absent From Work Due to Visit	4.4 Hours	Standard Deviation 3.5

Secondary

In-office Follow-up Burden: Patient Expenses

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

Time frame: 1 month

Population: All enrolled subjects who completed some portion of the caregiver burden survey and satisfied the inclusion/exclusion criteria were included.

Arm	Measure	Value (MEAN)	Dispersion
Remote Arm	In-office Follow-up Burden: Patient Expenses	15.0 Dollars	Standard Deviation 21

Secondary

State-Anxiety Scale

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

Time frame: 1, 3, 6, 9, 12, and 15 month visit

Population: 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	Measure	Group	Value (MEAN)	Dispersion
Remote Arm	State-Anxiety Scale	1 month	31.0 Scores on a scale	Standard Deviation 10.9
Remote Arm	State-Anxiety Scale	3 month	30.3 Scores on a scale	Standard Deviation 10.6
Remote Arm	State-Anxiety Scale	6 month	30.0 Scores on a scale	Standard Deviation 11.1
Remote Arm	State-Anxiety Scale	9 month	30.5 Scores on a scale	Standard Deviation 11.5
Remote Arm	State-Anxiety Scale	12 month	30.2 Scores on a scale	Standard Deviation 11.7
Remote Arm	State-Anxiety Scale	15 month	31.0 Scores on a scale	Standard Deviation 12.4
In-Office Arm	State-Anxiety Scale	12 month	31.2 Scores on a scale	Standard Deviation 12
In-Office Arm	State-Anxiety Scale	1 month	32.1 Scores on a scale	Standard Deviation 12
In-Office Arm	State-Anxiety Scale	9 month	30.6 Scores on a scale	Standard Deviation 11.2
In-Office Arm	State-Anxiety Scale	3 month	31.6 Scores on a scale	Standard Deviation 11.8
In-Office Arm	State-Anxiety Scale	15 month	32.7 Scores on a scale	Standard Deviation 12.8
In-Office Arm	State-Anxiety Scale	6 month	30.7 Scores on a scale	Standard Deviation 11

Comparison: 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.p-value: 0.217Mixed Models Analysis

Secondary

Symptomatic AT/AF Alerts

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

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

Population: All enrolled remote patients who experienced at least one AT/AF alert were included in the analysis. AT/AF alerts there were not classified by the clinician as symptomatic or asymptomatic were excluded from the analysis.

Arm	Measure	Value (NUMBER)
Remote Arm	Symptomatic AT/AF Alerts	73 Alerts

Regression, Logistic

Secondary

Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations

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

Time frame: From event onset to clinical decision

Population: All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
Remote Arm	Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations	6.7 Days	Standard Deviation 13.3
In-Office Arm	Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations	16.7 Days	Standard Deviation 24.4

Comparison: 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.p-value: <0.00195% CI: [-13.1, -6.9]t-test, 2 sided

Secondary

Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations

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

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

Population: All enrolled subjects who experienced at least one event and satisfied the inclusion/exclusion criteria were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
Remote Arm	Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations	0.8 Days	Standard Deviation 4.9
In-Office Arm	Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations	0.7 Days	Standard Deviation 3.3

Comparison: 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.p-value: 0.77995% CI: [-0.8, 1]t-test, 2 sided

Secondary

Trait-Anxiety Scale

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

Time frame: 1, 3, 6, 9, 12, and 15 months visits

Arm	Measure	Group	Value (MEAN)	Dispersion
Remote Arm	Trait-Anxiety Scale	1 month	31.2 Scores on a scale	Standard Deviation 10.5
Remote Arm	Trait-Anxiety Scale	3 month	29.8 Scores on a scale	Standard Deviation 9.6
Remote Arm	Trait-Anxiety Scale	6 month	29.6 Scores on a scale	Standard Deviation 10.3
Remote Arm	Trait-Anxiety Scale	9 month	29.7 Scores on a scale	Standard Deviation 10.6
Remote Arm	Trait-Anxiety Scale	12 month	29.6 Scores on a scale	Standard Deviation 10.7
Remote Arm	Trait-Anxiety Scale	15 month	30.7 Scores on a scale	Standard Deviation 11.1
In-Office Arm	Trait-Anxiety Scale	12 month	30.5 Scores on a scale	Standard Deviation 11.5
In-Office Arm	Trait-Anxiety Scale	1 month	32.1 Scores on a scale	Standard Deviation 11.4
In-Office Arm	Trait-Anxiety Scale	9 month	30.6 Scores on a scale	Standard Deviation 10.9
In-Office Arm	Trait-Anxiety Scale	3 month	31.3 Scores on a scale	Standard Deviation 11.3
In-Office Arm	Trait-Anxiety Scale	15 month	30.8 Scores on a scale	Standard Deviation 11.6
In-Office Arm	Trait-Anxiety Scale	6 month	30.8 Scores on a scale	Standard Deviation 10.7

Secondary

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

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

Time frame: 1, 3, 6, 9, 12, and 15 months visits

Population: 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	Measure	Group	Value (MEAN)	Dispersion
Remote Arm	Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)	1 month standard deviation	0.181 Volts	Standard Deviation 0.202
Remote Arm	Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)	3 month standard deviation	0.117 Volts	Standard Deviation 0.142
Remote Arm	Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)	6 month standard deviation	0.118 Volts	Standard Deviation 0.138
Remote Arm	Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)	9 month standard deviation	0.121 Volts	Standard Deviation 0.154
Remote Arm	Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)	12 month standard deviation	0.132 Volts	Standard Deviation 0.142
Remote Arm	Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)	15 month standard deviation	0.135 Volts	Standard Deviation 0.149
Remote Arm	Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)	1 month range	0.500 Volts	Standard Deviation 0.606
Remote Arm	Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)	3 month range	0.324 Volts	Standard Deviation 0.418
Remote Arm	Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)	6 month range	0.326 Volts	Standard Deviation 0.419
Remote Arm	Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)	9 month range	0.345 Volts	Standard Deviation 0.476
Remote Arm	Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)	12 month range	0.374 Volts	Standard Deviation 0.428
Remote Arm	Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)	15 month range	0.381 Volts	Standard Deviation 0.459

Other Pre-specified

Length of Hospital Stay (LOS)

LOS per cardiovascular hospitalization

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

Population: All enrolled subjects who satisfied the inclusion/exclusion criteria and had at least one cardiovascular hospitalization were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
Remote Arm	Length of Hospital Stay (LOS)	3.3 Days	Standard Error 0.15
In-Office Arm	Length of Hospital Stay (LOS)	4.0 Days	Standard Error 0.18

Comparison: 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.p-value: 0.00295% CI: [0.7, 0.9]negative binomial model

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026

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

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues

Actions Taken for HCU Visits

AT/AF Alert Treatment

CareLink Transmission Compliance

Clinically Meaningful Alerts

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

Health Care Utilization (HCU)

Health Care Utilization: TEEs

In-office Follow-up Burden: Distance Traveled

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

In-office Follow-up Burden: Patient Expenses

State-Anxiety Scale

Symptomatic AT/AF Alerts

Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations

Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations

Trait-Anxiety Scale

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

Length of Hospital Stay (LOS)